Carpal Tunnel | Post-operative Analgesia in Elective, Soft-tissue Hand Surgery
Carpal Tunnel research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Age greater than or equal to 18 - Male or Female (non-pregnant) - Elective, soft tissue hand surgery indicated based on diagnosis made by either clinical exam or diagnostic studies (ie nerve conduction study, EMG) or a combination of the two (carpal tunnel release, trigger finger release, first dorsal compartment release, ganglion cyst excision, second extensor compartment release) - Subjects are capable of giving informed consent Exclusion Criteria: - Allergy to study medication - Any pre-existing pain condition requiring analgesia - Fibromyalgia - Recent upper gastrointestinal bleeding - Coagulopathy (primary or medication-related) - Renal impairment - Liver disease - Pregnancy - Patients who consent to the study but require unexpected admission, including those requiring admission resulting from operative complications, will be excluded before randomization
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
De Quervain Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Acetaminophen/HydrocodonePatients will be treated with acetaminophen 325 mg / Hydrocodone 5 mg
Drug:Acetaminophen/IbuprofenAcetaminophen 500 mg / Ibuprofen 400 mg
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Acetaminophen/Ibuprofen (AIGU) GroupAcetaminophen 325 mg and Hydrocodone 5 mg
Acetaminophen/Hydrocodone (AH) GroupAcetaminophen 500 mg and Ibuprofen 400 mg
Enrolling by invitation
Start Date: February 10, 2015
Completed Date: December 31, 2019
Phase: Phase 4
Primary Outcome: Efficacy comparison utilizing Visual Analog Scale (VAS), Pain Catastrophizing Scale, Likert Pain Score and Mean daily pain values
Secondary Outcome: Incidence of adverse effects
Study sponsors, principal investigator, and references
Principal Investigator: Alexander Payatakes, M.D.
Lead Sponsor: Alexander Payatakes, M.D.
Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012 Apr;37(4):645-50. doi: 10.1016/j.jhsa.2012.01.035. Epub 2012 Mar 10.