Sensory Function After Wound Instillation of Capsaicin
This study has been completed.
Information provided by:
First received: December 20, 2007
Last updated: January 29, 2008
Last verified: January 2008
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
||Observational Model: Cohort
Time Perspective: Prospective
||Cutaneous Sensory Function After Wound Instillation of Capsaicin During Groin Hernia Repair
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:
| Study Start Date:
| Study Completion Date:
Capsaicin treated patients
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.
Placebo treated patients
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Adult males with primary unilateral groin hernia
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583180
|Hørsholm, Denmark, 2970 |
||Henrik Kehlet, M.D, Ph. D.
No publications provided
||Henrik Kehlet, Rigshospitalet
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 20, 2007
||January 29, 2008
||Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee
Keywords provided by Rigshospitalet, Denmark:
Primary and/or secondary hyperalgesia
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 01, 2015
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents