Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
42 participants
OBSERVATIONAL
2008-01-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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A
Capsaicin treated patients
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.
P
Placebo treated patients
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Rigshospitalet
Principal Investigators
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Henrik Kehlet, M.D, Ph. D.
Role: STUDY_DIRECTOR
Rigshospitalet, Denmark
Locations
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Hørshol Sygehus
Hørsholm, , Denmark
Countries
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Other Identifiers
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4975-2008-01
Identifier Type: -
Identifier Source: org_study_id