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Sensory Function After Wound Instillation of Capsaicin

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ClinicalTrials.gov Identifier: NCT00583180
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : January 30, 2008
Sponsor:
Information provided by:
Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment
Primary Hyperalgesia Drug: Capsaicin

Study Type : Observational
Estimated Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cutaneous Sensory Function After Wound Instillation of Capsaicin During Groin Hernia Repair
Study Start Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
Drug Information available for: Capsaicin
U.S. FDA Resources

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



Primary Outcome Measures :
  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 [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Frequency of chronic pain [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583180


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

Responsible Party: Henrik Kehlet, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00583180     History of Changes
Other Study ID Numbers: 4975-2008-01
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: January 30, 2008
Last Verified: January 2008

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
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs