Prospective Pain Study Comparing Different Treatments After Hand Surgery

NCT03597308 | Completed

• 1 other identifier: 2018Ilyas
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

• Numeric rating Scale for Pain

  11-point numeric rating scale (NRS) for pain

  2 weeks post-op

Study Arms (3)

Opioid Group

ACTIVE COMPARATOR

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

NSAID group

ACTIVE COMPARATOR

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

Acetaminophen

ACTIVE COMPARATOR

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

Interventions

5mg of Oxycodone every 6 hours as needed for pain DRUG

5mg of Oxycodone every 6 hours as needed for pain

Opioid Group

600mg of Ibuprofen every 6 hours as needed for pain DRUG

600mg of Ibuprofen every 6 hours as needed for pain

NSAID group

500mg of Acetaminophen every 6 hours as needed for pain DRUG

500mg of Acetaminophen every 6 hours as needed for pain

Acetaminophen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Health Services Needs and Demand

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 24, 2018
• Study Start: March 17, 2017
• Primary Completion: July 14, 2017
• Study Completion: August 1, 2017
• Last Updated: July 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)