Does a two-day pretreatment with capsaicin reduce postoperative hyperalgesia and pain in surgical patients

Phase 1

• Conditions: postoperative secondary mechanical hyperalgesia and postoperative pain; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2015-003208-22-AT
• Lead Sponsor: Wilhelminen hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-01
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•male or female, at least 18 years of age
•planned elective surgery requiring incision of the abdominal wall
•currently pain free or suffering from spontaneous pain in the last 24 hours of less than 4 on the numeric rating scale in the area of planned surgery
•able to understand, read, and write German
•willing and able to give informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

•patients undergoing scheduled surgery with less than 3 full days until surgery date
•patients undergoing surgery with planned local anesthetic procedures (peripheral nerve block, , epidural or spinal anesthesia) or planned use of NMDA-receptor antagonists (i.e. ketamine i.v. or p.o.)
•patients scheduled for postoperative controlled respiratory treatment at the intensive care unit (ICU)
•patients under the age of 18
•patients suffering from acute or chronic pain with an intensity of greater than 3 on the numeric rating scale (spontaneous within the last 24 hours)
•patients currently on prescribed regular analgesic medication
•patients suffering from any known psychiatric condition
•patients suffering from unstable hypertension
•patients with implanted cardiac converter or pacemaker
•pregnancy or breast-feeding
•known abuse of alcoholic beverages or any illegal drug
•known allergy against interventional or placebo medication, patch contents or study assessment devices
•unable or unwilling to give informed consent
•unable or unwilling to follow investigator’s instructions
•unable or unwilling to comply with study protocol
•patients suffering from any known medical conditions which may interact with study medication, study objectives, or compliance of subject with study tasks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified