Post-operative Analgesia in Elective, Soft-tissue Hand Surgery

Phase 4

Terminated

• Conditions: Carpal Tunnel; Ganglion Cyst; Trigger Finger; De Quervain Disease
• Interventions: Drug: Acetaminophen/Hydrocodone; Drug: Acetaminophen/Ibuprofen

• Registration Number: NCT02029235
• Lead Sponsor: Alexander Payatakes, M.D.

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.

Study Timeline

• Study First Submitted: 2014-01-03
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Study Start: 2015-02-10
• Primary Completion: 2017-11-17
• Study Completion: 2018-06-30
• Results First Submitted: 2018-10-22
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-12
• Last Update Submitted: 2018-12-12
• Results First Posted: 2018-12-13
• Last Update Posted: 2018-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen/Hydrocodone (AH) Group	Acetaminophen/Hydrocodone	Acetaminophen 325 mg and Hydrocodone 5 mg
Acetaminophen/Ibuprofen (AIBU) Group	Acetaminophen/Ibuprofen	Acetaminophen 500 mg and Ibuprofen 400 mg

Primary Outcome Measures

Name	Time	Method
Efficacy Comparison of Pain Intensity Level	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 Outcome Measures

Name	Time	Method
Efficacy Comparison of Pain Relief	1 week postoperatively	Subjects asked to fill out a patient diary recording their pain relief (on a Likert scale) one hour after taking study medication every 4 hours.; Daily average pain relief scores are reported as a score on a scale of 0-3, with higher score meaning better outcome.; The daily average pain relief scores were assessed daily for 1 week post-operatively, then compared using generalized linear mixed-effects models

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States