Sensory Function After Wound Instillation of Capsaicin

Study Overview
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Brief Summary
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The use of capsaicin as a potential analgesic drug for postoperative pain relies on the ability of capsaicin to induce membrane lysis of c-nerve fibers. In a previous randomized placebo controled blinded study of this effect we found a significant effect of capsaicin versus placebo. Before surgery all patients were examined by quantitative sensory testing to evaluate sensory function. In this study an identical sensory testing will examine if changes to the sensory function in capsaicin treated patients is identical to placebo treated patients.No new intervention will be performed

Official Title
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Cutaneous Sensory Function After Wound Instillation of Capsaicin During Groin Hernia Repair

Conditions
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Primary Hyperalgesia

Intervention / Treatment
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* Drug: Capsaicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary groin hernia planned to undergo Lichtenstein mesh repair Ability to use pain scales American Society of Anesthesiologist class I or II based upon medical history, physical examination, and screening laboratory results Willing to take oral pain medication (acetaminophen, ibuprofen) for the first week Willing to fill out a diary for four weeks following surgery. Exclusion Criteria: A previous lower abdominal surgical procedure Bupivacaine, acetaminophen, ibuprofen, or tramadol A medical condition likely to alter wound healing or pain ratings Systolic blood pressure greater than 150 or diastolic greater than 95 mm Hg Contraindication to general anesthesia Bilateral hernia repair A history of drug or alcohol abuse within the past two years Use of antihypertensive, antidepressant, or psychotropic drug that has not been stable for 3 months Use of an investigational drug within 3 months or scheduled to receive an investigational drug other than ALGRX 4975 during the study period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Capsaicin treated patients | Drug: Capsaicin<br>* instillation of sterile water or 1000 micrograms of capsaicin into the wound at the end of open groin hernia surgery in previous study.no new intervention will be performed in the current study.<br>* Other names: ADLEA;|
| P<br>Placebo treated patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in sensory function before and 2 years after groin hernia repair in patients with and without capsaicin instillation, evaluated by quantitative sensory testing |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of chronic pain |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary and/or secondary hyperalgesia, hypoesthesia