Sensory Function After Wound Instillation of Capsaicin

NCT00583180 | Completed

• 1 other identifier: 4975-2008-01
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Hyperalgesia

Keywords

Primary and/or secondary hyperalgesia; hypoesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frequency of chronic pain

  2 years

Study Arms (2)

A

Capsaicin treated patients

Drug: Capsaicin

P

Placebo treated patients

Interventions

Capsaicin DRUG

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.

Also known as: ALGRX 4975, ADLEA

A

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult males with primary unilateral groin hernia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Hørshol Sygehus

Hørsholm, 2970, Denmark

Location

MeSH Terms

Conditions

Hyperalgesia; Hypesthesia

Interventions

Capsaicin; ALGRX-4975

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Henrik Kehlet, M.D, Ph. D.

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: January 30, 2008

Record last verified: 2008-01

Locations

DK (1)