Prospective Pain Study Comparing Different Treatments After Hand Surgery

PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING OXYCODONE, IBUPROFEN AND ACETAMINOPHEN AFTER WIDE AWAKE HAND SURGERY

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03597308

Enrollment

210

Registered

2018-07-24

Start date

2017-03-17

Completion date

2017-08-01

Last updated

2018-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Pain

Brief summary

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.

Interventions

DRUG5mg of Oxycodone every 6 hours as needed for pain

5mg of Oxycodone every 6 hours as needed for pain

DRUG600mg of Ibuprofen every 6 hours as needed for pain

600mg of Ibuprofen every 6 hours as needed for pain

DRUG500mg of Acetaminophen every 6 hours as needed for pain

500mg of Acetaminophen every 6 hours as needed for pain

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Numeric rating Scale for Pain	2 weeks post-op	11-point numeric rating scale (NRS) for pain

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026