Prospective Pain Study Comparing Different Treatments After Hand Surgery

Rothman Institute Orthopaedics

Status: Completed

Conditions: Post-operative Pain

Treatments: Drug: 600mg of Ibuprofen every 6 hours as needed for pain; Drug: 500mg of Acetaminophen every 6 hours as needed for pain; Drug: 5mg of Oxycodone every 6 hours as needed for pain

Study type: Interventional

Funder types: Other

Identifiers

NCT03597308

2018Ilyas

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 3 patient groups

Opioid Group

Active Comparator group

Treatment:

Drug: 5mg of Oxycodone every 6 hours as needed for pain

NSAID group

Active Comparator group

Treatment:

Drug: 600mg of Ibuprofen every 6 hours as needed for pain

Acetaminophen

Active Comparator group

Treatment:

Drug: 500mg of Acetaminophen every 6 hours as needed for pain