Treatment of chronic pain post inguinal hernia repair By

Transcription

Treatment of chronic pain
post inguinal hernia repair
By
WorkSafeBC Evidence-Based Practice Group
Dr. Craig W. Martin, Senior Medical Advisor
November 2012
Clinical Services – Worker and Employer Services
Treatment of chronic pain post inguinal hernia repair
i
About this report
Published: November 2012
About the Evidence-Based Practice Group
The Evidence-Based Practice Group was established to address the many medical and policy issues that
WorkSafeBC officers deal with on a regular basis. Members apply established techniques of critical appraisal
and evidence-based review of topics solicited from both WorkSafeBC staff and other interested parties such as
surgeons, medical specialists, and rehabilitation providers.
Cite as
WorkSafeBC Evidence-Based Practice Group, Edeer D, Martin CW. Treatment of chronic pain post inguinal
hernia repair. Richmond, BC: WorkSafeBC Evidence-Based Practice Group; November 2012. Available at:
http:/worksafebc.com/health_care_providers/Assets/PDF/ChronicPainPostHerniaRepair2012.pdf
Contact Information
Evidence-Based Practice Group
WorkSafeBC
PO Box 5350 Stn Terminal
Vancouver BC V6B 5L5
Email
Phone
Toll-free



[email protected]
604 279-7417
1 888 967-5377 ext 7417
View other systematic reviews by the Evidence-Based Practice Group online at:
http://worksafebc.com/evidence
www.worksafebc.com/evidence
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Table of contents
About this report .................................................................................................................................................... i
List of abbreviations ............................................................................................................................................ iii
Background ........................................................................................................................................................... 1
Methods ................................................................................................................................................................ 2
Results ................................................................................................................................................................... 3
I. Efficacy studies.............................................................................................................................................. 3
II. Return to daily activities .............................................................................................................................. 3
III. Treatment modalities .................................................................................................................................. 4
IV. Practice guidelines and review papers ........................................................................................................ 6
Key messages ........................................................................................................................................................ 8
Limitations ............................................................................................................................................................ 9
Summary and conclusions .................................................................................................................................. 10
References ........................................................................................................................................................... 11
Appendix 1 .......................................................................................................................................................... 15
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List of abbreviations
CCT
Controlled clinical trial
IASP
International Association for the Study of Pain
MPR
Mesh plug repair
PHS
Prolene hernia system
PRF
Pulsed radiofrequency
QOL
Quality of life
RCT
Randomized controlled trial
SCS
Spinal cord stimulation
TAPP
Transabdominal preperitoneal patch plasty
TENS
Transcutaneous electrical nerve stimulation
TEP
Totally extraperitoneal patch plasty
VAS
Visual Analog Scale
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Background
Chronic pain following inguinal hernia repair is quite common and may reduce quality of life.1-6 Determining
the etiology of this multifaceted condition can be challenging.
The response of a patient to hernia repair is affected by their pre- and post-operative physical and psychosocial state. Clinical and technical aspects of the surgical operation may also play a major role in short- and
long-term outcomes. The wide range of surgical techniques and materials available to choose from makes the
appropriate decision by the surgeon crucial to the long-term success of the repair. For example, a surgeon may
decide to perform an open or laparoscopic surgery; to use or not to use mesh; to select a light or heavy weight
mesh; to place the mesh in the preperitoneal or extraperitoneal area; to fit it with sutures or glue; and to
preserve or remove surrounding nerve(s).
Post-hernia repair pain is considered to be either “non-neuropathic” (resulting from scar tissue or mechanical
pressure) or “neuropathic” (resulting from nerve injury or compression) or a combination of both.2
Neuropathic pain is reported to be more prevalent.4 Kalliomaki et al. state that as measured by various quality
of life scales, “persistent post-herniorrhaphy pain is mainly neuropathic and has a substantial impact on healthrelated quality of life”.5 Though some authors studied chronic pain post-hernia repair at one year and
beyond,7-9 in general, pain lasting beyond three months from the operation is considered to be “chronic”.3,10-13
It is suggested that chronic post-operative pain dissipates over time.8,14,15 Regardless, after hernia repair many
patients experience chronic pain for a significant period of time. A 2012 Cochrane review by Willaert et al.
reports the risk for post-hernia repair chronic pain to range from 7.83% to 40.47%16 and 2 to 4% of reported
post-herniorrhaphy chronic pain is serious enough to affect patients’ daily activities.13 The incidence of
debilitating pain is estimated to be 0.5 to 6% by an international group of experts.17 Given the frequency of
hernia repair operations performed worldwide (annually, 2800 per million in the US and Europe),18 a
considerable number of patients are affected by this disabling chronic pain. For example, in 2003, in the US,
over 800,000 inguinal hernia operations were performed,19 possibly leaving an estimated 2000 patients with
post-operative chronic pain affecting their daily lives. Recently, in the US, the number of people suffering
from post-hernia repair disabling pain is estimated to be around 6,000 to 18,000 annually.20
Inguinal hernias also constitute a sizable proportion of work-related injury claims which require surgical
intervention. For example, in the period of 1987 – 2001, 5455 inguinal hernia claims were accepted at
WorkSafeBC.21 Considering the various published statistics, possibly more than 100 claimants have suffered
from post-operative chronic pain with a significant negative impact on their daily lives.
The objective of this review is to explore the literature around evidence-based treatment options for patients
with chronic pain post inguinal hernia repair.
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Methods
A literature search on electronic OvidSP databases was undertaken on July 26, 2012, employing the keywords
inguinal or groin hernia repair/herniorapphy/hernioplasty, chronic/persistent/neuropathic pain,
treatment/therapy; and combining these keywords with Boolean operators as appropriate.
The OvidSP databases included were: Evidence-based Medicine (EBM) Reviews (ACP Journal Club 1991 to
July 2012, Cochrane Central Register of Controlled Trials July 2012, Cochrane Database of Systematic
Reviews July 2012, Database of Abstracts of Reviews of Effects 3rd Quarter 2012, NHS Economic Evaluation
Database 3rd Quarter 2012), EMBASE 1980 to 2012 July 25, and Ovid MEDLINE® 1946 to Present with
Daily Update.
Limits were employed during searching. Only articles in English, on humans, studying adult populations, and
those that were published in the last 5 years were included. Study type was limited to controlled clinical trials,
comparative studies, meta-analysis, and randomized controlled trials (RCTs). A flow diagram of the study
selection methods is available in Appendix 1.
With the above-mentioned search strategy, we were not able to identify any studies on the treatment of posthernia repair chronic pain. We then hand-searched (with no limits on publication year or study type) the
reference lists of the potential articles collected in full-text during study selection. Additionally, we searched
the literature on a few specific treatment modalities suggested for post-hernia repair chronic pain, such as
neurectomy, pulsed radiofrequency (PRF), spinal cord stimulation (SCS) and transcutaneous electrical nerve
stimulation (TENS), with no restriction on study type, extending the publication date range back to 2000.
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Results
Most of the studies identified through our OvidSP databases search were efficacy studies comparing various
surgical techniques or materials used for inguinal hernia repair. In these studies, chronic pain was often studied
as a primary or a secondary outcome.7-9,14,16,22-35 Except for a few proposed protocols,11,36 studies specifically
on the “treatment of post-hernia repair chronic pain” were lacking. There were a few studies focusing on
prevention of post-hernia repair chronic pain,15,37,38 while others attempted to determine predisposing
factors.1,39
I. Efficacy studies
Efficacy studies on hernia repair surgical techniques and materials reported on different outcomes (e.g., hernia
recurrence, perioperative complications, hypoesthesia, surgery related chronic pain, quality of life). In a metaanalysis of studies comparing open vs. laparoscopic hernia repair techniques, O’Reilly et al. did not find one
specific technique to be consistently better than the others for all outcomes. For example, they found that
laparoscopic techniques were superior to open techniques in terms of chronic groin pain and numbness, but
were inferior in terms of perioperative morbidity.33
One problem regarding the use of chronic pain as an outcome of interest in efficacy studies of inguinal hernia
repair is the fact that there is no standard measurement for it.3,17 Hence, it is difficult to compare results from
different studies and to combine data to conduct a meta-analysis.
Table 1 lists efficacy studies found during our literature search which compared different surgical techniques
and materials and reported post-hernia repair chronic pain as an outcome of interest.
II. Return to daily activities
Our literature search also found studies reporting on “return to daily activities” or “return to work”. Eker et al.
found that “patients had faster time to return to daily activities (P<.002) and less absence from work (P=.001)”
after TEP procedure compared to Lichtenstein hernia repair.40 Similarly, time to post-operative recovery and
return to work were significantly shorter for TEP (P=.001) in the Bektas et al. study, which compared TEP and
darn plication techniques.31 Sick leave time was statistically significantly shorter with the TEP group compared
to the Lichtenstein group in both the Langeveld and Kouhia studies.7,26 Eklund et al. compared laparoscopic
and Lichtenstein inguinal hernia repair, and found time to recovery to be one of the risk factors to determine
post-hernia repair chronic pain. In a systematic review by Zhao et al., data from the included studies
comparing mesh plug repair (MPR) technique and prolene hernia system (PHS) repair to Lichtenstein’s
operation yielded shorter time to return to work. However, the difference between the groups was not
statistically significant in any of these comparisons.25 The Koch et al. study found that time to return to work
was statistically significantly shorter in patients with lightweight mesh compared to standard mesh.41 A 2010
meta-analysis by Karthikesalingam et al. found that time to return to work activities was significantly
shortened by laparoscopic surgery. However, there was significant statistical heterogeneity associated with this
outcome measure.9
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Table 1. Results related to post-hernia repair chronic pain in efficacy studies found during our literature search.
No statistically significant
difference between various
surgical techniques
No statistically significant
surgical materials
Statistically significant difference
between various surgical
techniques
Statistically significant
surgical materials
Amato 2012
Shouldice technique vs.
other open techniques
Langeveld 2010
Open mesh repair (Lichtenstein)
vs. TEP
Bektas 2011
TEP procedure vs.
darn plication technique
Campanelli 2012
Fibrin sealant vs. sutures
Markar 2010
Absorbable meshes vs.
nonabsorbable meshes
Kouhia 2009
Lichtenstein vs. TEP
Demetrashvili 2011
Lichtenstein vs.
laparoscopic TAPP
Eklund 2007
Laparoscopic vs.
Lichtenstein repair
Karthikesalingam 2010
Laparoscopic vs.
conventional open surgery
Kucuk 2010
Moloney darn vs.
Lichtenstein procedure
Van Veen 2007
Mesh vs. non-mesh
primary inguinal hernia repair
Paajanen 2011
Tissue glue vs. absorbable
sutures in mesh fixation
Paajanen 2007
Conventional polypropylene mesh,
lightweight mesh or partly
absorbable mesh
Lovisetto 2007
Tissucol fibrin glue vs. staples
in laparoscopic TAPP repair
Nienhuijs 2007
Open preperitoneal Kugel vs.
standard open anterior
Lichtenstein procedure
O'Reilly 2012
Laparoscopic vs. open repair of
primary unilateral inguinal hernia
Pierides 2011
Various mesh types
Willaert 2012
Open preperitoneal techniques vs.
Lichtenstein repair
Zhao 2009
Lichtenstein’s operation vs.
MPR, or Lichtenstein’s operation
vs. PHS repair, or mesh plug vs.
PHS repair
III. Treatment modalities
We searched the literature for a number of specific treatment modalities which have been undertaken for posthernia repair chronic pain. We sought studies published from 2000 onwards, with no restrictions on study type.
a. Neurectomy
Causes, prevention, and surgical treatment of postherniorrhaphy neuropathic inguinodynia: Triple
neurectomy with proximal end implantation (Amid 2004)2
This paper reported on a case series of 225 patients suffering from chronic postherniorrhaphy neuralgia who
underwent triple neurectomy (resection of ilioinguinal, iliohypogastric, and genital nerves) with proximal end
implantation. All patients had a history of failed conventional pain management. The authors identified that out
of 225 patients, 100 had neuropathic pain. The follow up at six months showed that 80% of the total number of
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patients had full recovery, and with the exception of 4, all of the patients with workers’ compensation-related
cases were able to return to work without any restrictions. The authors supported this surgical approach
because it was a one-stage operation, avoiding repeat neurectomies. They underlined that “the most common
cause of nerve injury is failure to identify and protect the nerves, particularly when dissection is minimized in
order to complete the operation faster,” and they listed some technical recommendations for the success of
inguinal hernia-repair operations.
Management of Chronic Postoperative Groin Pain (Ducic 2008)10
The authors retrospectively studied 19 consecutive patients who were referred to their clinic for intractable
post-operative groin pain due to neuroma or nerve entrapment. All were offered neurectomies. The main
outcome of interest was a change in chronic pain pre- and post-neurectomy and was measured by patient selfassessment, using a Visual Analog Scale (VAS). The secondary outcome of interest was a 50% improvement
on a quality of life (QOL) scale after neurectomy. They reported that 84% of patients had significant pain relief
and improved QOL at a minimum of 1 year follow up after neurectomy. They recommended that neurectomy
be a choice for surgical treatment for post-hernia repair chronic pain if appropriate selection of patients and
surgical techniques are applied.
b. Pulsed Radiofrequency (PRF)
Pulsed Radiofrequency for the Treatment of Ilioinguinal Neuralgia after Inguinal Herniorrhaphy
(Rozen 2006)42
The authors reported on a case series of 5 patients with ilioinguinal neuralgia secondary to inguinal repair who
received pulsed radiofrequency (PRF) as a treatment. The authors distinguished pulsed radiofrequency from
“neurodestructive” radiofrequency treatment, which they defined to involve “a constant high frequency
(500kHz), high temperature (80 – 82°C) electrical current” application to the tissue via an electrode. In
contrast, they defined PRF as delivering “high intensity currents in pulses, allowing heat to dissipate during the
latent period so that neurodestructive temperatures are not reached and neuritis-like reactions do not occur.”
They treated each of the five patients at T12, L1, and L2 vertebral levels with root PRF at 42°C for 120
seconds per level. Four of the five patients responded to PRF successfully, with less pain, and “have been
satisfactorily treated by oral medication to date.”
c. Spinal Cord Stimulation (SCS)
Spinal Cord Stimulation as Alternative Treatment for Chronic Post-Herniorrhaphy Pain (Yakovlev
2010)43
The authors studied 15 consecutive patients (from 3 clinics) with intractable chronic pain post-herniorrhaphy.
Conservative therapy had been tried and failed for all of the patients. The authors applied Spinal Cord
Stimulation (SCS), a technique “to interrupt pain transmission from the viscera to the spinal cord,” via epidural
access gained at T12/L1 or L1/L2 with the final leads located at T7-T8-T9. After all patients completed a 2day trial, they were switched to permanent leads within a period of 2 to 4 weeks. At 12-month follow up, the
authors reported significant pain relief (75% reduction in VAS) and decreased or discontinued pain medication
use in all of the patients. This study is a report of a case series with 15 patients and there is no comparison
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group. The authors acknowledged this and called for prospective studies to compare SCS to other less invasive
interventions.
d. Combined Spinal Cord and Peripheral Nerve Field Stimulation (SCS and PNFS)
Combined Spinal Cord and Peripheral Nerve Field Stimulation for Persistent Post-Herniorrhaphy Pain
(Lepski 2012)6
The authors conducted a case series study of four patients with chronic post-herniorrhaphy neuropathic pain.
They implanted electrodes into the epidural area of the spinal canal (generally T8-9) and into the subcutaneous
tissue in the inguinal region. The test phase was 14 days, with 3 days using SCS, 3 days using PNFS, 3 days
using both (SCS + PNFS), and 5 days off. The study found that combined SCS + PNFS obtained better results
for neuropathic post-hernia pain, suggesting an additive effect of the simultaneous use of the two treatments
for pain control. The follow-up period was 2 to 11 months. All four patients had some improvement in pain
levels, with three having a stronger response. At follow-up, two patients were no longer taking medication.
Given the possible benefits of lower medication intake, fewer surgical interventions, and reduced hospital stay
after SCS + PNFS application, the authors suggested that a trial to test the cost-effectiveness of this treatment
modality for patients with post-herniorrhaphy neuropathic pain was worthwhile.
e. Transcutaneous Electrical Nerve Stimulation (TENS)
The few studies we identified which utilized transcutaneous electrical nerve stimulation (TENS) for the
treatment of post-hernia repair pain focused on post-operative pain, but not on pain continuing beyond three
months and considered to be chronic.44-46
IV. Practice guidelines and review papers
We also searched the literature for practice guidelines and review papers on the treatment of post-hernia repair
chronic pain.
Surgical management of chronic pain after inguinal hernia repair (Aasvang 2005)18
Aasvang and Kehlet undertook a literature review to examine neurectomy and mesh or staple removal as
treatment options for chronic pain after inguinal hernia repair. They identified 35 papers on “surgical treatment
for groin pain” and eliminated 18 of them (some did not have data on chronic pain, some were not available,
etc.) They also cross-checked retrieved articles for additional references. The authors found the methodological
quality of the neurectomy studies to be poor (none of the studies were randomized; the majority were
observational studies describing usual clinical practice – with no comparison group; and some were case
reports). “Lack of objective assessment of pain before operation, previous treatment, lack of
neurophysiological examination to achieve a specific diagnosis, no standardized surgical procedure in a well
defined patient population, lack of randomization and control group, and absence of detailed follow-up”
hindered the interpretation of the findings that in general reported favorable outcomes. Regarding mesh or
staple removal, the authors concluded that there were not sufficient studies at that time to reach any
conclusion.
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Pulsed Radiofrequency in the Treatment of Persistent Pain after Inguinal Herniotomy: A Systematic
Review (Werner 2012)20
Werner et al. undertook a systematic review of the literature on pulsed radiofrequency, which utilizes
electromagnetic energy for the treatment of persistent pain following inguinal herniotomy. They searched
PubMed, Embase and CINAHL and identified four case reports with a total of eight patients. The outcome of
interest to measure the efficacy of PRF was pain relief and was reported to vary between 63% and 100%.
During a follow up period of 3 to 9 months, no adverse effects or complications were reported. The authors
stated that based on these four studies the evidence was low quality and the strength of recommendation was
weak to moderate. In the discussion section of their paper the authors made six recommendations to improve
the quality of PRF studies: The neuropathic pain component should be determined through neurologic
examination with sensory testing, and should not be anticipated; Pain and pain-related functional impairment
should be measured before and after treatment; Double-blinded, placebo-controlled study technique is needed
to estimate the true value of diagnostic blocks applied before PRF; To establish evidence-based analgesia,
sham-controlled studies are needed; Ultrasound-guided techniques should be used to document correct
anatomic location, and to perform diagnostic blocks and the therapeutic procedure; How pain and pain-related
functional impairment, and also adverse effects, have changed over time should be followed for 6 to 12
months, with appropriate intervals. The authors concluded that the guidelines they provided in the paper will
help improve management strategies for this group of chronic pain-disabled patients.
Inguinodynia following Lichtenstein tension-free hernia repair: A review (Hakeem 2011)13
In 2011, Hakeem and Shanmugam published a review discussing various aspects related to “chronic groin
pain” which exists beyond 3 months post Lichtenstein hernia repair. The solution they suggested was
preventative: “Careful intra-operative handling of inguinal structures and better patient counselling pre- and
post-herniorraphy.”
International guidelines for prevention and management of post-operative chronic pain following
inguinal hernia surgery (Alfieri 2011)17
The authors reported the results of an international consensus conference held in Rome in 2008, which
included both a working group and 200 people from an international audience of experts on the topic of postoperative chronic pain following inguinal hernia surgery. The group worked on consensus terminology and
definitions. They suggested that the International Association for the Study of Pain (IASP) definition of
“chronic pain”47 be modified to include “only chronic pain that is present from 3 months after surgery and
which lasts beyond 6 months after surgery.” As a preventative approach for avoiding post-hernia repair chronic
pain, this group of experts suggested that during hernia repair all three inguinal nerves need to be identified
and preserved. If this was not possible due to structural issues, they suggested that any nerve in the way of a
repair should be completely removed and not just cut. The experts also suggested that if a patient suffers posthernia repair chronic pain, medical pain management should be the first choice. If a patient does not respond to
medical treatment for more than 1 year after the operation, and if their quality of daily life has been
compromised by the intensity of the pain, the experts then recommended triple neurectomy. Moreover, they
noted that this operation needs to be performed by experienced surgeons.
November 2012
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Key messages
-
Effective management of chronic pain following inguinal hernia repair should be based on a thorough
examination of the etiology (history, physical examination, imaging studies, and other tests as needed).
-
Neuropathic and non-neuropathic pain may require different pain management approaches.
-
For non-neuropathic pain, depending on the cause of pain, a variety of approaches may be appropriate
(e.g., non-steroidal anti-inflammatory drugs (NSAIDs), antibiotic therapy, local anesthetic/steroid
injections, surgical re-exploration and mesh removal, or repair of recurrent hernia).
-
Medical management of neuropathic pain should start with medical pain therapy (oral/local analgesics,
opioids, sometimes anti-depressants) and if required switch to various treatment modalities such as
nerve blocks with injection of local anaesthetics (with or without steroids), neurolysis, or minimally
invasive techniques such as spinal cord stimulation (SCS), transcutaneous electrical nerve stimulation
(TENS), or pulsed radiofrequency (PRF). Surgical intervention, often neurectomy, may be indicated.
-
There is no consensus in the literature about which patients are appropriate candidates to benefit from
surgical therapy (i.e., peripheral neurectomy).
-
There is no consensus in the literature around clinical timing to switch from conservative therapy to
surgical therapy. However, in general, patients are not offered surgical exploration before conservative
therapy has been prescribed for at least 6 months.
-
Patients who undergo surgical treatment for chronic post-herniorrhaphy pain should be selected
carefully and should be informed about the risks of the intervention.
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Limitations
Until now, few studies have focused on the treatment options for post-inguinal hernia repair chronic pain.
Proposals for RCTs/meta-analyses have only recently been reported.11,36 The few studies available are not
controlled trials, have small sample sizes, studied selected and usually consecutive groups of patients, do not
all use standard tools to measure outcomes of interest, and do not have a consistent definition of “chronic pain”
after hernia repair. With a lack of controlled comparative studies, the existing reviews and guidelines on the
topic are based on clinical experience and expert opinion.
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Summary and conclusions
Until conclusive studies are published on the treatment of chronic pain post-inguinal hernia repair, the
common best practices of chronic pain management utilizing a biopsychosocial approach (e.g., medical pain
management supported with patient and caregiver education, return-to-activity programs, and services from
behavioral health experts) should apply. It remains important to tailor the pain management approach
according to the type of the pain diagnosed (i.e., neuropathic, non-neuropathic, or both). Newly emerging
treatment modalities (e.g., pulsed radiofrequency (PRF), spinal cord stimulation (SCS), transcutaneous
electrical nerve stimulation (TENS)) should not be endorsed without a thorough evaluation of the individual
patient.
With the large number of primary studies on the efficacy of hernia repair techniques, the number of systematic
reviews and meta-analyses on the topic of “post-hernia repair chronic pain” is likely to increase. Conclusions
from these publications can be expected to challenge current clinical practice and to address some of the
surgery-related factors contributing to post-hernia repair chronic pain.
November 2012
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15
Appendix 1
Flow diagram (Study selection)
OvidSP databases search results
(n= 603)
Inclusion limits employed:
-
Humans
Adults
English
Last 5 years
Randomized controlled
trials, controlled clinical
trials, comparative
studies, meta-analyses
Records excluded
(n= 523)
Results after limits employed
(n= 80)
Abstracts collected and reviewed
for 80 citations
Abstracts excluded
(n= 75)
Full text articles collected
(n= 5)
No relevant articles found
(n=0)
References screened and
additional searches on specific
treatment modalities conducted
November 2012

Treatment of chronic pain post inguinal hernia repair By

Transcription

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