Clinical Trial: Post-operative Analgesia in Elective, Soft-tissue Hand Surgery

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Post-operative Analgesia in Elective, Soft-tissue Hand Surgery: A Randomized, Double Blind Comparison of Acetaminophen/Ibuprofen Versus Acetaminophen/Hydrocodone

Brief Summary: The purpose of this research study is to find out which combination of pain medications following surgery work the best and result in the fewest side effects.

Detailed Summary: This is a prospective, randomized, double-blind study comparing the efficacy of acetaminophen/hydrocodone (AH) to acetaminophen/ibuprofen (AIBU) in providing adequate post-operative pain relief in elective, soft tissue hand surgery patients.
Sponsor: Alexander Payatakes, M.D.

Current Primary Outcome: Efficacy comparison utilizing Visual Analog Scale (VAS), Pain Catastrophizing Scale, Likert Pain Score and Mean daily pain values [ Time Frame: 2 weeks post-operatively ]

Patients will be asked to return to the research site a total of 2 times - preop and 2 weeks post-operative. Patients will receive a phone call 7 days after surgery.


Original Primary Outcome: Efficacy comparison utilizing Visual Analog Scale (VAS), Likert Pain Score and Mean daily pain values [ Time Frame: 2 weeks post-operatively ]

Patients will be asked to return to the research site a total of 3 times - surgery, 7 days after surgery and 14 days after surgery.


Current Secondary Outcome: Incidence of adverse effects [ Time Frame: 2 weeks post-operatively ]

Any adverse effects will be recorded and analyzed, including time to stopping medication, incidence of medication discontinuation, and need for additional analgesics


Original Secondary Outcome: Same as current

Information By: Milton S. Hershey Medical Center

Dates:
Date Received: January 3, 2014
Date Started: February 2015
Date Completion: December 2021
Last Updated: January 10, 2017
Last Verified: January 2017