Sensory Function After Wound Instillation of Capsaicin

January 29, 2008 updated by: Rigshospitalet, Denmark

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hørsholm, Denmark, 2970
        • Hørshol Sygehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Adult males with primary unilateral groin hernia

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Capsaicin treated patients
Drug: Capsaicin
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.
Other Names:
  • ALGRX 4975
  • ADLEA
P
Placebo treated patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of chronic pain
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Director: Henrik Kehlet, M.D, Ph. D., Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (Estimate)

December 31, 2007

Study Record Updates

Last Update Posted (Estimate)

January 30, 2008

Last Update Submitted That Met QC Criteria

January 29, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4975-2008-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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