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

Phase 4TerminatedNCT02029235

Alexander Payatakes, M.D.72 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Carpal Tunnel Ganglion Cyst Trigger Finger De Quervain Disease

Interventions

Acetaminophen/IbuprofenDRUG

Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free

Acetaminophen/HydrocodoneDRUG

Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Efficacy Comparison of Pain Intensity Level

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.

Time frame: 1 week post-operatively

Secondary Outcomes

Efficacy Comparison of Pain Relief

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

Time frame: 1 week postoperatively

Data from ClinicalTrials.gov

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