Post-operative Analgesia in Elective, Soft-tissue Hand Surgery: A Randomized, Double Blind Comparison of Acetaminophen/Ibuprofen Versus Acetaminophen/Hydrocodone
Overview
- Phase
- Phase 4
- Intervention
- Acetaminophen/Ibuprofen
- Conditions
- Carpal Tunnel
- Sponsor
- Alexander Payatakes, M.D.
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Efficacy Comparison of Pain Intensity Level
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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 Description
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.
Investigators
Alexander Payatakes, M.D.
Principal Investigator / Sponsor
Milton S. Hershey Medical Center
Eligibility Criteria
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
Arms & Interventions
Acetaminophen/Ibuprofen (AIBU) Group
Acetaminophen 500 mg and Ibuprofen 400 mg
Intervention: Acetaminophen/Ibuprofen
Acetaminophen/Hydrocodone (AH) Group
Acetaminophen 325 mg and Hydrocodone 5 mg
Intervention: Acetaminophen/Hydrocodone
Outcomes
Primary Outcomes
Efficacy Comparison of Pain Intensity Level
Time Frame: 1 week post-operatively
Subjects asked to fill out a patient diary recording their pain intensity level (on 100mm Visual Analog Scale) prior to taking study medication every 4 hours. The daily average pain intensity levels are reported as a score on a scale of 0-100, with higher score meaning worse outcome. The daily average pain levels were assessed daily for 1 week post-operatively, then compared between the 2 groups using a two-group Student's t-test.
Secondary Outcomes
- Efficacy Comparison of Pain Relief(1 week postoperatively)