Does Re-surgery Improve Somatosensory Outcomes in Persistent Pain After Groin Hernia Repair

NCT05238571 | Completed DMC

• 1 other identifier: H-2-2011-023-FE
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Patients With Persistent Severe Pain After Groin Hernia Repair

Keywords

groin hernia repair; chronic post-surgical pain; pain thresholds; patient reported outcome measures; reoperation; sensory thresholds

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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.

  3-6 months

Secondary Outcomes (2)

• Activity Assessment Scale (AAS)

  3-6 months

• Pain intensity scores (NRS)

  3-6 months

Interventions

Re-surgery PROCEDURE

Re-surgery with meshectomy and selective neurectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with persistent severe pain after groin hernia repair.

You may qualify if:

• 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.

You may not qualify if:

• All that contradicts the above.

Sponsors & Collaborators

• mads u werner: lead

Study Sites (1)

Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK

Copenhagen, 2100, Denmark

Location

Related Publications (13)

• 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.

  PMID: 32631293 BACKGROUND

• Chapman 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.

  PMID: 27908839 BACKGROUND

• Campanelli 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

• 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.

  PMID: 28025741 BACKGROUND

• HerniaSurge 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.

  PMID: 29330835 BACKGROUND

• Jorgensen 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.

  PMID: 30820781 BACKGROUND

• Andresen 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.

  PMID: 29670394 BACKGROUND

• Jensen 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.

  PMID: 31415351 BACKGROUND

• Werner 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.

  PMID: 24849039 BACKGROUND

• Bischoff 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.

  PMID: 23494661 BACKGROUND

• Aasvang 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.

  PMID: 15962258 BACKGROUND

• Aasvang 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.

  PMID: 19212190 BACKGROUND

• Linderoth 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.

  PMID: 21479588 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, MD, DMSci

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: April 24, 2009
• Primary Completion: March 19, 2015
• Study Completion: March 19, 2015
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)