Prospective Pain Study Comparing Different Treatments After Hand Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-17

Study Completion Date

2017-08-01

Brief Summary

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The purpose of the study is to evaluate the efficacy of three different types of pain medication (Oxycodone - an opioid, Ibuprofen - a non-steroidal anti-inflammatory, and Acetaminophen - a non-opioid analgesic) in the management of postoperative pain following single soft tissue procedures of the hand and wrist performed exclusively under local anesthesia without sedation. The results of this study will help define optimal prescribing guidelines following the two most common hand surgeries while also potentially validating the use of opioid alternatives post-operatively in order to help mitigate excessive or unnecessary dispensal of opioid analgesics.

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Detailed Description

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Conditions

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Post-operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Opioid Group

Group Type ACTIVE_COMPARATOR

5mg of Oxycodone every 6 hours as needed for pain

Intervention Type DRUG

5mg of Oxycodone every 6 hours as needed for pain

NSAID group

Group Type ACTIVE_COMPARATOR

600mg of Ibuprofen every 6 hours as needed for pain

Intervention Type DRUG

600mg of Ibuprofen every 6 hours as needed for pain

Acetaminophen

Group Type ACTIVE_COMPARATOR

500mg of Acetaminophen every 6 hours as needed for pain

Intervention Type DRUG

500mg of Acetaminophen every 6 hours as needed for pain

Interventions

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5mg of Oxycodone every 6 hours as needed for pain

Intervention Type DRUG

600mg of Ibuprofen every 6 hours as needed for pain

Intervention Type DRUG

500mg of Acetaminophen every 6 hours as needed for pain

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients indicated to undergo primary, unilateral carpal tunnel release or trigger finger release surgery under local anesthesia alone.
2. Age eligibility is \> 18 years of age.
3. Local anesthesia with 1% lidocaine with 1:100,000 epinephrine and Bicarbonate.

Exclusion Criteria

1. Bilateral procedures.
2. Additional soft tissue or boney procedures performed simultaneously.
3. The use of sedation and/or general anesthesia.
4. Pediatric patients (age \< 18 years).
5. Pregnant female patients.
6. Non-English speaking patients.
7. Known allergies or medical contraindications to Oxycodone, Ibuprofen, Acetaminophen.
8. History of chronic pain and/or narcotic use preoperatively.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No