A National Center for Persistent Severe Pain After Groin Hernia Repair

NCT03713047 | Completed

• 1 other identifier: H-2-2011-023
• Study Type: observational
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective, consecutive cohort study presents nationwide 5-year outcome data on patients with severe persistent pain after groin hernia repair (SPG). The inclusion criteria were SPG-related impairment of physical and social life. Two-hundred-four out of 222 patients (92%) were analyzed. Relevant surgical records were obtained, and examinations were by standardized clinical and neurophysiological tests. Patients demonstrating pain sensitivity to pressure algometry in the groin were evaluated regarding exploratory surgery, while patients with putative neuropathic pain received pharmacotherapy. Questionnaires at baseline (Q0) and five-year (Q5Y) were used in outcome-analyses of pain-intensity (numeric rating scale \[NRS\] 0-10) and the pain-related effect on the activity-of-daily-living (Activities Assessment Scale, AAS).

Conditions

Inguinal Hernia; Chronic Pain

Keywords

Questionnaire; Long term follow up; Surgical Procedure; Groin hernia repair; Neuropathy; Inflammation; Chronic pain; ADL-functions; Psychometrics; Quantitative sensory testing (QST)

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Numeric Rating Scale (NRS; 0-10 units)

  2010-2015

• Activity of Daily Living (ADL) score

  Activities Assessment Scale (AAS; 8 specified physical activities; 0-8 units each)

  2010-2015

Secondary Outcomes (2)

• Assessments of Anxiety and Depression

  2010-2015

• Assessment of Pain Catastrophizing

  2010-2015

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 severe persistent pain after groin hernia repair with psychophysical disability referred to the dedicated tertiary center for these patients on a nationwide basis.

You may qualify if:

• Severe persistent pain after groin hernia repair (activity-related or maximal pain intensity \> 7 NRS-units \[numeric rating scale 0-10\])
• Severe persistent pain after groin hernia repair-related serious impairment of working and social life.

You may not qualify if:

• Minors or persons of legally incompetence
• Participants, who do not speak or understand Danish
• Participants, who cannot cooperate with the investigator or the examination procedure
• Recurrent hernia
• Known neurological disease or disorders in the groin area of other origin
• Psychiatric disease
• Abuse of alcohol or drugs - according to investigator's evaluation

Sponsors & Collaborators

• University of Copenhagen: lead

Related Publications (14)

• 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

• 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

• Niccolai P, Ouchchane L, Libier M, Beouche F, Belon M, Vedrinne JM, El Drayi B, Vallet L, Ruiz F, Biermann C, Duchene P, Chirat C, Soule-Sonneville S, Duale C, Dubray C, Schoeffler P. Persistent neuropathic pain after inguinal herniorrhaphy depending on the procedure (open mesh v. laparoscopy): a propensity-matched analysis. Can J Surg. 2015 Apr;58(2):114-20. doi: 10.1503/cjs.008314.

  PMID: 25799247 BACKGROUND

• Cohen SP, Raja SN. Prevention of chronic postsurgical pain: the ongoing search for the holy grail of anesthesiology. Anesthesiology. 2013 Feb;118(2):241-3. doi: 10.1097/ALN.0b013e31827d4129. No abstract available.

  PMID: 23340346 BACKGROUND

• Kehlet H, Roumen RM, Reinpold W, Miserez M. Invited commentary: Persistent pain after inguinal hernia repair: what do we know and what do we need to know? Hernia. 2013 Jun;17(3):293-7. doi: 10.1007/s10029-013-1109-4. Epub 2013 May 21. No abstract available.

  PMID: 23686405 BACKGROUND

• Chen DC, Hiatt JR, Amid PK. Operative management of refractory neuropathic inguinodynia by a laparoscopic retroperitoneal approach. JAMA Surg. 2013 Oct;148(10):962-7. doi: 10.1001/jamasurg.2013.3189.

  PMID: 23903521 BACKGROUND

• Magnusson N, Gunnarsson U, Nordin P, Smedberg S, Hedberg M, Sandblom G. Reoperation for persistent pain after groin hernia surgery: a population-based study. Hernia. 2015 Feb;19(1):45-51. doi: 10.1007/s10029-014-1340-7. Epub 2014 Dec 18.

  PMID: 25519077 BACKGROUND

• Nikkolo C, Lepner U. Chronic pain after open inguinal hernia repair. Postgrad Med. 2016 Jan;128(1):69-75. doi: 10.1080/00325481.2016.1121090. Epub 2015 Dec 4.

  PMID: 26567717 BACKGROUND

• Kehlet H, Bay-Nielsen M; Danish Hernia Database Collaboration. Nationwide quality improvement of groin hernia repair from the Danish Hernia Database of 87,840 patients from 1998 to 2005. Hernia. 2008 Feb;12(1):1-7. doi: 10.1007/s10029-007-0285-5. Epub 2007 Oct 16.

  PMID: 17939015 BACKGROUND

• McCarthy M Jr, Jonasson O, Chang CH, Pickard AS, Giobbie-Hurder A, Gibbs J, Edelman P, Fitzgibbons R, Neumayer L. Assessment of patient functional status after surgery. J Am Coll Surg. 2005 Aug;201(2):171-8. doi: 10.1016/j.jamcollsurg.2005.03.035.

  PMID: 16038812 BACKGROUND

• Aasvang EK, Gmaehle E, Hansen JB, Gmaehle B, Forman JL, Schwarz J, Bittner R, Kehlet H. Predictive risk factors for persistent postherniotomy pain. Anesthesiology. 2010 Apr;112(4):957-69. doi: 10.1097/ALN.0b013e3181d31ff8.

  PMID: 20234307 BACKGROUND

• Bischoff JM, Koscielniak-Nielsen ZJ, Kehlet H, Werner MU. Ultrasound-guided ilioinguinal/iliohypogastric nerve blocks for persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled, crossover trial. Anesth Analg. 2012 Jun;114(6):1323-9. doi: 10.1213/ANE.0b013e31824d6168. Epub 2012 Mar 30.

  PMID: 22467891 BACKGROUND

• Aasvang EK, Kehlet H. Persistent sensory dysfunction in pain-free herniotomy. Acta Anaesthesiol Scand. 2010 Mar;54(3):291-8. doi: 10.1111/j.1399-6576.2009.02137.x. Epub 2009 Oct 15.

  PMID: 19839945 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 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal; Chronic Pain; Inflammation

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Pathologic Processes

Study Officials

• Mads U Werner, MD, PhD

  Neuroscience Center, Copenhagen University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: October 19, 2018
• Study Start: January 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 19, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share