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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Post-operative Analgesia in Elective, Soft-tissue Hand Surgery: A Randomized, Double Blind Comparison of Acetaminophen/Ibuprofen Versus Acetaminophen/Hydrocodone

Conditions
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Carpal Tunnel, Ganglion Cyst, Trigger Finger, De Quervain Disease

Intervention / Treatment
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* Drug: Acetaminophen/Ibuprofen
* Drug: Acetaminophen/Hydrocodone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetaminophen/Ibuprofen (AIBU) Group<br>Acetaminophen 500 mg and Ibuprofen 400 mg | Drug: Acetaminophen/Ibuprofen<br>* Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free<br>* Other names: Ibuprofen/Advil/Motrin;|
| Active Comparator: Acetaminophen/Hydrocodone (AH) Group<br>Acetaminophen 325 mg and Hydrocodone 5 mg | Drug: Acetaminophen/Hydrocodone<br>* Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free<br>* Other names: Norco;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 week post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 week postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult, soft-tissue hand surgery