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/IbuprofenPostoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free
Drug:Acetaminophen/HydrocodonePostoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free
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 (AIBU) GroupAcetaminophen 500 mg and Ibuprofen 400 mg
Acetaminophen/Hydrocodone (AH) GroupAcetaminophen 325 mg and Hydrocodone 5 mg
Start Date: February 10, 2015
Completed Date: June 30, 2018
Phase: Phase 4
Primary Outcome: Efficacy Comparison of Pain Intensity Level
Secondary Outcome: Efficacy Comparison of Pain Relief
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.