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Prospective Pain Study Comparing Different Treatments After Hand Surgery

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ClinicalTrials.gov Identifier: NCT03597308
Recruitment Status : Completed
First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

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.

Condition or disease Intervention/treatment Phase
Post-operative Pain Drug: 5mg of Oxycodone every 6 hours as needed for pain Drug: 600mg of Ibuprofen every 6 hours as needed for pain Drug: 500mg of Acetaminophen every 6 hours as needed for pain Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING OXYCODONE, IBUPROFEN AND ACETAMINOPHEN AFTER WIDE AWAKE HAND SURGERY
Actual Study Start Date : March 17, 2017
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Opioid Group Drug: 5mg of Oxycodone every 6 hours as needed for pain
5mg of Oxycodone every 6 hours as needed for pain

Active Comparator: NSAID group Drug: 600mg of Ibuprofen every 6 hours as needed for pain
600mg of Ibuprofen every 6 hours as needed for pain

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




Primary Outcome Measures :
  1. Numeric rating Scale for Pain [ Time Frame: 2 weeks post-op ]
    11-point numeric rating scale (NRS) for pain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597308


Locations
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United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics

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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT03597308     History of Changes
Other Study ID Numbers: 2018Ilyas
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Oxycodone
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants