A National Center for Persistent Severe Pain After Groin Hernia Repair

Chronic Pain Clinical Trial

— Q5Y  

Official title:

A National Center for Persistent Severe Pain After Groin Hernia Repair: Five-year Prospective Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03713047
• Other study ID #: H-2-2011-023
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: September 1, 2015

Study information

• Verified date: October 2018
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Severe persistent pain after groin hernia repair (SPG) causes psychophysical disability and impairs quality-of-life for a considerable number of individuals each year.1-3 In the United States, 600,000 groin hernia repairs (GHR) are performed annually, and a conservative estimate is that 2%, corresponding to 12,000 individuals, each year will develop this debilitating pain condition.4 The management of SPG remains a daunting challenge to the medical profession 5, often requiring multidisciplinary efforts.1,6 Several surgical procedures have indicated substantial pain-relieving effects in SPG1,7 however few well-powered, controlled studies have been presented.8,9 In pharmacological and neuromodulation procedures, most studies are still case-based or uncontrolled.

In 2010, the authors established a dedicated tertiary center for SPG-patients open for referral on a nationwide basis. The objectives were, first, to analyze the pathophysiological mechanism behind the pain, second, to implement optimal medical and surgical pain management and third, to perform clinical SPG-research projects. Standardized clinical and neurophysiological tests guided the management paradigm for each patient. Treatment outcomes were evaluated prospectively using baseline questionnaires (Q0) and a 5-year questionnaire (Q5Y) mailed at the end of 2014 to all patients referred to the center.

The focus of the present study is first, to present clinical, neurophysiological and psychometric data on SPG-patients at referral, and second, to evaluate and compare efficacies of exploratory surgical and non-surgical treatment, based on a consecutive follow-up cohort of 222 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: September 1, 2015
• Est. primary completion date: September 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Pain
• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Oct 16. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: J Am Coll Surg. 2005 Nov;201(5):826. — View Citation

Niccolaï P, Ouchchane L, Libier M, Beouche F, Belon M, Vedrinne JM, El Drayi B, Vallet L, Ruiz F, Biermann C, Duchêne P, Chirat C, Soule-Sonneville S, Dualé 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. — View Citation

Nikkolo C, Kirsimägi Ü, 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Numeric Rating Scale (NRS; 0-10 units)	2010-2015
Primary	Activity of Daily Living (ADL) score	Activities Assessment Scale (AAS; 8 specified physical activities; 0-8 units each)	2010-2015
Secondary	Assessments of Anxiety and Depression	Hospital Anxiety and Depression Scale (HADS; 14 item scale; 0-21 units)	2010-2015
Secondary	Assessment of Pain Catastrophizing	Pain Catastrophizing Scale (PCS; 13 item scale; 0-65 units)	2010-2015