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NCT03597308 Clinical Trial

Prospective Pain Study Comparing Different Treatments After Hand Surgery

Post-operative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03597308
Other study ID # 2018Ilyas
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 17, 2017
Est. completion date August 1, 2017

Study information
Verified date July 2018
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date August 1, 2017
Est. primary completion date July 14, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Rothman Institute Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

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