Patients With Persistent Severe Pain After Groin Hernia RepairNCT05238571
Does Re-surgery Improve Somatosensory Outcomes in Persistent Pain After Groin Hernia Repair
An observational study of Patients With Persistent Severe Pain After Groin Hernia Repair, run by mads u werner at 1 site in Denmark.
Trial summary
Groin hernia repair is accompanied by persistent severe pain in 2-4% of the patients significantly restraining psychophysical functions. Re-surgery with meshectomy and selective neurectomy may improve the pain condition, compared to non-surgical alternatives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Persistent Severe Pain After Groin Hernia Repair
- What is being tested?
- Re-surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Apr 2009to 19 Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with persistent severe pain after groin hernia repair.
Who may be able to join
- Patients with persistent severe pain (activity-related or maximal pain intensity > 7 NRS-scores [numeric pain rating scale 0-10]) following unilateral, uncomplicated, open groin hernia repair.
Who cannot join
- All that contradicts the above.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK
Copenhagen, 2100
About this study
Official title: Somatosensory Outcomes Following Re-surgery in Persistent Severe Pain After Groin Hernia Repair
Groin hernia repair is accompanied by persistent severe pain in 2-4% of the patients significantly restraining psychophysical functions. Re-surgery with meshectomy and selective neurectomy may improve the pain condition, compared to non-surgical alternatives. In the current study, the primary objective was to examine and describe the underlying pathophysiological perturbations by quantitative somatosensory testing before and after re-surgery.
Read the detailed description
Persistent severe pain occurring in the aftermath of a surgical procedure is frequently associated with significant impairment of physical and psycho-social functions. After groin hernia repair (GHR), 2-4% of patients develop persistent severe pain. The GHR procedure, previously considered belonging to "minor" surgeries, qualifies as a rather complex procedure performed in a territory with a high density of nerve fibers, accommodating essential functions for locomotion and reproduction. More than 20 million repairs are performed annually worldwide, and consequently, it is estimated that 400.000-800.000 patients each year will develop persistent severe pain after the groin hernia repair (PSPG). Management of PSPG is medically challenging and may require re-surgery with mesh removal and selective neurectomy. After re-surgery for pain after open primary GHR, a potential pain-relieving effect, as well as an improvement of the deteriorated physical functions, has been demonstrated.
Quantitative somatosensory testing (QST) is an investigational psychophysiological tool with the potential to uncover the putative pathophysiological substrate in PSPG, i.e., neuropathic and inflammatory constituents. The method may also be used to quantitate changes induced by the re-surgery. Since re-surgery is a neuroablative procedure, essentially performed in previously damaged tissue, it is of interest to examine the extent of neurological perturbations, i.e., 'loss' and 'gain' of sensory functions and the relation to clinical outcome measures.
The authors are only aware of one previous PSPG-study (n = 21) finding that re-surgery, including meshectomy and selective neurectomy, was associated with increased pain pressure thresholds, decreased pain ratings and improved pain-related functional measures. The objectives of the current study, comparing pre with post-re-surgery data, were first to perform a more detailed analysis of the quantitative somatosensory data regarding 'loss' and 'gain' of sensory functions and their relation to clinical outcome measures. Second, to corroborate the clinical outcome findings of the previous study using a threefold larger cohort.
- Being tested
- Re-surgery
- Keywords
- groin hernia repair, chronic post-surgical pain, pain thresholds, patient reported outcome measures, reoperation, sensory thresholds
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-surgeryProcedure or surgery
Re-surgery with meshectomy and selective neurectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal thresholds
Warmth detection threshold (WDT), cool detection threshold, heat pain threshold (HPT) and cold pain threshold (CPT) are made by a computerized contact thermode (Thermotest, Somedic AB, Sweden) with an active thermal surface of 12.5 cm^2 (2.5 x 5.0 cm^2). The thresholds are determined from a baseline temperature of 32°C with a ramp rate of + 1°C/s. Cut-offs for heat and cold are 50°C and 5°C, respectively. The assessments are made in triplicate and the mean values are used in the statistical analyses.
Measured: 3-6 months
Pressure algometry
Deep-tissue pain sensitivity is assessed using a hand-held pressure algometer with a neoprene-coated tip of area 1.0 cm2 (Somedic AB, Sweden), as previously described. The algometer is applied perpendicularly to the skin with a pressure rate of 30 kPa/s. The study subject is told to report the pressure pain threshold (PPT) by activating the button device when pain is perceived. The cut-off limit is 350 kPa. Testing is done in triplicate and the average value is used in the statistical analyses.
Measured: 3-6 months
Suprathreshold heat stimulation
A short tonic heat stimulus (heating area 12.5 cm^2; ramp rate: 1°C/s, plateau: 47°C, 5 s; STH) is delivered in order to evaluate the suprathreshold heat pain perception (NRS).
Measured: 3-6 months
Temporal summation
Temporal summation test, i.e., the perception in response to repetitive (0.3 to 3 Hz) mechanical stimulation [i.e., wind-up like pain: WUP], indicates presence of central sensitization. The repetitive 1 Hz stimuli for 60 s are either dynamically delivered by a brush or statically delivered by a polyamide filament (one nominal rank below TPT). The study subjects are told to report the level of pain (NRS) every 15 s-1 during the stimulation. Signs of aftersensations are followed 60 s after discontinuation of the stimulation, and the intensity of discomfort or pain is rated by NRS.
Measured: 3-6 months
Secondary outcomes (2)
Activity Assessment Scale (AAS)
Changes in AAS scores before and thre-six months after operation
Measured: 3-6 months
Pain intensity scores (NRS)
Changes in pain intensity scores (NRS) at rest, on average and maximally before and thre-six months after operation
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start24 Apr 2009
- Primary completion19 Mar 2015
- Study completion19 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Patients With Persistent Severe Pain After Groin Hernia RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- mads u werner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, mads u werner, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238571
- Sponsor's protocol ID
- H-2-2011-023-FE
- Status last verified
- Nov 2022
- First submitted
- 3 Feb 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available as a supplement to the published scientific article.
Publications
Bande D, Molto L, Pereira JA, Montes A. Chronic pain after groin hernia repair: pain characteristics and impact on quality of life. BMC Surg. 2020 Jul 6;20(1):147. doi: 10.1186/s12893-020-00805-9.
PubMed 32631293Chapman CR, Vierck CJ. The Transition of Acute Postoperative Pain to Chronic Pain: An Integrative Overview of Research on Mechanisms. J Pain. 2017 Apr;18(4):359.e1-359.e38. doi: 10.1016/j.jpain.2016.11.004. Epub 2016 Nov 28.
PubMed 27908839Campanelli G, Bruni PG, Morlacchi A, Cavalli M. Chronic Pain after Inguinal Hernia Repair. In: Campanelli G, editor. Inguinal Hernia Surgery. Milano: Springer Milan; 2017. p. 157-68.
Nikkolo C, Kirsimagi U, Vaasna T, Murruste M, Suumann J, Seepter H, Lepner U. Prospective study evaluating the impact of severity of chronic pain on quality of life after inguinal hernioplasty. Hernia. 2017 Apr;21(2):199-205. doi: 10.1007/s10029-016-1569-4. Epub 2016 Dec 26.
PubMed 28025741HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.
PubMed 29330835Jorgensen SG, Oberg S, Rosenberg J. Treatment of longstanding groin pain: a systematic review. Hernia. 2019 Dec;23(6):1035-1044. doi: 10.1007/s10029-019-01919-7. Epub 2019 Feb 28.
PubMed 30820781Andresen K, Rosenberg J. Management of chronic pain after hernia repair. J Pain Res. 2018 Apr 5;11:675-681. doi: 10.2147/JPR.S127820. eCollection 2018.
PubMed 29670394Jensen EK, Ringsted TK, Bischoff JM, Petersen MA, Rosenberg J, Kehlet H, Werner MU. A national center for persistent severe pain after groin hernia repair: Five-year prospective data. Medicine (Baltimore). 2019 Aug;98(33):e16600. doi: 10.1097/MD.0000000000016600.
PubMed 31415351Werner MU. Management of persistent postsurgical inguinal pain. Langenbecks Arch Surg. 2014 Jun;399(5):559-69. doi: 10.1007/s00423-014-1211-9. Epub 2014 May 23.
PubMed 24849039Bischoff JM, Enghuus C, Werner MU, Kehlet H. Long-term follow-up after mesh removal and selective neurectomy for persistent inguinal postherniorrhaphy pain. Hernia. 2013 Jun;17(3):339-45. doi: 10.1007/s10029-013-1073-z. Epub 2013 Mar 15.
PubMed 23494661Aasvang E, Kehlet H. Surgical management of chronic pain after inguinal hernia repair. Br J Surg. 2005 Jul;92(7):795-801. doi: 10.1002/bjs.5103.
PubMed 15962258Aasvang EK, Kehlet H. The effect of mesh removal and selective neurectomy on persistent postherniotomy pain. Ann Surg. 2009 Feb;249(2):327-34. doi: 10.1097/SLA.0b013e31818eec49.
PubMed 19212190Linderoth G, Kehlet H, Aasvang EK, Werner MU. Neurophysiological characterization of persistent pain after laparoscopic inguinal hernia repair. Hernia. 2011 Oct;15(5):521-9. doi: 10.1007/s10029-011-0815-z. Epub 2011 Apr 9.
PubMed 21479588
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatosensory Outcomes Following Re-surgery in Persistent Severe Pain After Groin Hernia Repair
- ClinicalTrials.gov ID
- NCT05238571
- Acronym / sponsor ID
- H-2-2011-023-FE
- Keywords
- groin hernia repair, chronic post-surgical pain, pain thresholds, patient reported outcome measures, reoperation, sensory thresholds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- mads u wernerUniversity, hospital or other
- Study start
- 24 Apr 2009 (actual)
- Primary completion
- 19 Mar 2015 (actual)
- Study completion
- 19 Mar 2015 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Groin hernia repair is accompanied by persistent severe pain in 2-4% of the patients significantly restraining psychophysical functions. Re-surgery with meshectomy and selective neurectomy may improve the pain condition, compared to non-surgical alternatives. In the current study, the primary objective was to examine and describe the underlying pathophysiological perturbations by quantitative somatosensory testing before and after re-surgery.
Detailed description
Persistent severe pain occurring in the aftermath of a surgical procedure is frequently associated with significant impairment of physical and psycho-social functions. After groin hernia repair (GHR), 2-4% of patients develop persistent severe pain. The GHR procedure, previously considered belonging to "minor" surgeries, qualifies as a rather complex procedure performed in a territory with a high density of nerve fibers, accommodating essential functions for locomotion and reproduction. More than 20 million repairs are performed annually worldwide, and consequently, it is estimated that 400.000-800.000 patients each year will develop persistent severe pain after the groin hernia repair (PSPG). Management of PSPG is medically challenging and may require re-surgery with mesh removal and selective neurectomy. After re-surgery for pain after open primary GHR, a potential pain-relieving effect, as well as an improvement of the deteriorated physical functions, has been demonstrated.
Quantitative somatosensory testing (QST) is an investigational psychophysiological tool with the potential to uncover the putative pathophysiological substrate in PSPG, i.e., neuropathic and inflammatory constituents. The method may also be used to quantitate changes induced by the re-surgery. Since re-surgery is a neuroablative procedure, essentially performed in previously damaged tissue, it is of interest to examine the extent of neurological perturbations, i.e., 'loss' and 'gain' of sensory functions and the relation to clinical outcome measures.
The authors are only aware of one previous PSPG-study (n = 21) finding that re-surgery, including meshectomy and selective neurectomy, was associated with increased pain pressure thresholds, decreased pain ratings and improved pain-related functional measures. The objectives of the current study, comparing pre with post-re-surgery data, were first to perform a more detailed analysis of the quantitative somatosensory data regarding 'loss' and 'gain' of sensory functions and their relation to clinical outcome measures. Second, to corroborate the clinical outcome findings of the previous study using a threefold larger cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with persistent severe pain after groin hernia repair.
Key inclusion criteria (1 listed)
- Patients with persistent severe pain (activity-related or maximal pain intensity > 7 NRS-scores [numeric pain rating scale 0-10]) following unilateral, uncomplicated, open groin hernia repair.
Key exclusion criteria (1 listed)
- All that contradicts the above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Re-surgeryRe-surgery with meshectomy and selective neurectomy | Procedure or surgery | – |
Primary outcome
Thermal thresholds
Time frame: 3-6 months
Warmth detection threshold (WDT), cool detection threshold, heat pain threshold (HPT) and cold pain threshold (CPT) are made by a computerized contact thermode (Thermotest, Somedic AB, Sweden) with an active thermal surface of 12.5 cm^2 (2.5 x 5.0 cm^2). The thresholds are determined from a baseline temperature of 32°C with a ramp rate of + 1°C/s. Cut-offs for heat and cold are 50°C and 5°C, respectively. The assessments are made in triplicate and the mean values are used in the statistical analyses.
Pressure algometry
Time frame: 3-6 months
Deep-tissue pain sensitivity is assessed using a hand-held pressure algometer with a neoprene-coated tip of area 1.0 cm2 (Somedic AB, Sweden), as previously described. The algometer is applied perpendicularly to the skin with a pressure rate of 30 kPa/s. The study subject is told to report the pressure pain threshold (PPT) by activating the button device when pain is perceived. The cut-off limit is 350 kPa. Testing is done in triplicate and the average value is used in the statistical analyses.
Suprathreshold heat stimulation
Time frame: 3-6 months
A short tonic heat stimulus (heating area 12.5 cm^2; ramp rate: 1°C/s, plateau: 47°C, 5 s; STH) is delivered in order to evaluate the suprathreshold heat pain perception (NRS).
Temporal summation
Time frame: 3-6 months
Temporal summation test, i.e., the perception in response to repetitive (0.3 to 3 Hz) mechanical stimulation [i.e., wind-up like pain: WUP], indicates presence of central sensitization. The repetitive 1 Hz stimuli for 60 s are either dynamically delivered by a brush or statically delivered by a polyamide filament (one nominal rank below TPT). The study subjects are told to report the level of pain (NRS) every 15 s-1 during the stimulation. Signs of aftersensations are followed 60 s after discontinuation of the stimulation, and the intensity of discomfort or pain is rated by NRS.
2 secondary outcomes
Activity Assessment Scale (AAS)
Time frame: 3-6 months
Pain intensity scores (NRS)
Time frame: 3-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Background: PubMed 32631293Bande D, Molto L, Pereira JA, Montes A. Chronic pain after groin hernia repair: pain characteristics and impact on quality of life. BMC Surg. 2020 Jul 6;20(1):147. doi: 10.1186/s12893-020-00805-9.
- Background: PubMed 27908839Chapman CR, Vierck CJ. The Transition of Acute Postoperative Pain to Chronic Pain: An Integrative Overview of Research on Mechanisms. J Pain. 2017 Apr;18(4):359.e1-359.e38. doi: 10.1016/j.jpain.2016.11.004. Epub 2016 Nov 28.
- BackgroundCampanelli G, Bruni PG, Morlacchi A, Cavalli M. Chronic Pain after Inguinal Hernia Repair. In: Campanelli G, editor. Inguinal Hernia Surgery. Milano: Springer Milan; 2017. p. 157-68.
- Background: PubMed 28025741Nikkolo C, Kirsimagi U, Vaasna T, Murruste M, Suumann J, Seepter H, Lepner U. Prospective study evaluating the impact of severity of chronic pain on quality of life after inguinal hernioplasty. Hernia. 2017 Apr;21(2):199-205. doi: 10.1007/s10029-016-1569-4. Epub 2016 Dec 26.
- Background: PubMed 29330835HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.
- Background: PubMed 30820781Jorgensen SG, Oberg S, Rosenberg J. Treatment of longstanding groin pain: a systematic review. Hernia. 2019 Dec;23(6):1035-1044. doi: 10.1007/s10029-019-01919-7. Epub 2019 Feb 28.
- Background: PubMed 29670394Andresen K, Rosenberg J. Management of chronic pain after hernia repair. J Pain Res. 2018 Apr 5;11:675-681. doi: 10.2147/JPR.S127820. eCollection 2018.
- Background: PubMed 31415351Jensen EK, Ringsted TK, Bischoff JM, Petersen MA, Rosenberg J, Kehlet H, Werner MU. A national center for persistent severe pain after groin hernia repair: Five-year prospective data. Medicine (Baltimore). 2019 Aug;98(33):e16600. doi: 10.1097/MD.0000000000016600.
- Background: PubMed 24849039Werner MU. Management of persistent postsurgical inguinal pain. Langenbecks Arch Surg. 2014 Jun;399(5):559-69. doi: 10.1007/s00423-014-1211-9. Epub 2014 May 23.
- Background: PubMed 23494661Bischoff JM, Enghuus C, Werner MU, Kehlet H. Long-term follow-up after mesh removal and selective neurectomy for persistent inguinal postherniorrhaphy pain. Hernia. 2013 Jun;17(3):339-45. doi: 10.1007/s10029-013-1073-z. Epub 2013 Mar 15.
- Background: PubMed 15962258Aasvang E, Kehlet H. Surgical management of chronic pain after inguinal hernia repair. Br J Surg. 2005 Jul;92(7):795-801. doi: 10.1002/bjs.5103.
- Background: PubMed 19212190Aasvang EK, Kehlet H. The effect of mesh removal and selective neurectomy on persistent postherniotomy pain. Ann Surg. 2009 Feb;249(2):327-34. doi: 10.1097/SLA.0b013e31818eec49.
- Individual participant dataSharing planned: Yes. Data will be made available as a supplement to the published scientific article.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Persistent Severe Pain After Groin Hernia Repair, run by mads u werner at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal thresholds (time frame: 3-6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05238571, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.