Sensory Function After Wound Instillation of Capsaicin

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00583180
First received: December 20, 2007
Last updated: January 29, 2008
Last verified: January 2008
  Purpose

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


Condition Intervention
Primary Hyperalgesia
Drug: Capsaicin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cutaneous Sensory Function After Wound Instillation of Capsaicin During Groin Hernia Repair

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of chronic pain [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: January 2008
Study Completion Date: January 2008
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult males with primary unilateral groin hernia

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583180

Locations
Denmark
Hørshol Sygehus
Hørsholm, Denmark, 2970
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Director: Henrik Kehlet, M.D, Ph. D. Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Henrik Kehlet, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00583180     History of Changes
Other Study ID Numbers: 4975-2008-01
Study First Received: December 20, 2007
Last Updated: January 29, 2008
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
Primary and/or secondary hyperalgesia
hypoesthesia

Additional relevant MeSH terms:
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014