Clinical trial NCT03713047: A National Center for Persistent Severe Pain After Groin Hernia Repair
Official title: A National Center for Persistent Severe Pain After Groin Hernia Repair: Five-year Prospective Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
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)
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity
timeFrame: 2010-2015
measure: Activity of Daily Living (ADL) score
timeFrame: 2010-2015
Secondary outcomes:
measure: Assessments of Anxiety and Depression
timeFrame: 2010-2015
measure: Assessment of Pain Catastrophizing
timeFrame: 2010-2015
Other outcomes:
Locations:
Study officials:
affiliation: Neuroscience Center, Copenhagen University Hospital, Denmark
name: Mads U Werner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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