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OpenTrials
Completed

NCT Number: NCT03597308

Prospective Pain Study Comparing Different Treatments After Hand Surgery

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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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

5mg of Oxycodone every 6 hours as needed for pain

Drug

5mg of Oxycodone every 6 hours as needed for pain

600mg of Ibuprofen every 6 hours as needed for pain

Drug

600mg of Ibuprofen every 6 hours as needed for pain

500mg of Acetaminophen every 6 hours as needed for pain

Drug

500mg of Acetaminophen every 6 hours as needed for pain

Primary outcomes

  1. Numeric rating Scale for Pain

    Time frame: 2 weeks post-op

    11-point numeric rating scale (NRS) for pain

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 24, 2018
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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