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Trial record 1 of 4 for:    Ibuprofen acetaminophen hand surgery
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Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery

This study is currently recruiting participants.
Verified July 2017 by University of Pennsylvania
Sponsor:
ClinicalTrials.gov Identifier:
NCT02647788
First Posted: January 6, 2016
Last Update Posted: July 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose
The purpose of this research study is to find out if taking Acetaminophen with Ibuprofen (e.g. Tylenol + Advil), a non-opioid regimen, provides the same type of pain relief after hand surgery compared to Acetaminophen and codeine (e.g. Tylenol 3), an opioid regimen.

Condition Intervention Phase
Pain, Postoperative Drug: Acetaminophen/Ibuprofen Drug: Acetaminophen/Codeine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study, Blinded Randomized Control Trial, Single Center Study to Compare Acetaminophen & Codeine Versus Ibuprofen/Acetaminophen for Pain Control and Patient Satisfaction After Ambulatory Hand Surgery

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Assessing change in pain using the Visual Analogue Scale Pain Score [ Time Frame: 3 times a day each day after hand surgery (at dinner time, before going to sleep and in the middle of the night), until post-op appointment (between 4 and 8 days after surgery) ]
    To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen).


Secondary Outcome Measures:
  • Quality of Recovery-9 (QoR-9). [ Time Frame: Postoperative Day 2 ]
    To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction through Quality of Recovery (QoR) scores in ambulatory hand surgery.


Estimated Enrollment: 126
Study Start Date: December 2015
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acetaminophen/Ibuprofen
Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg
Drug: Acetaminophen/Ibuprofen
After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit
Other Name: Tylenol/Advil
Active Comparator: Acetaminophen/Codeine
Group 2: Acetaminophen 300mg, Codeine 30 mg
Drug: Acetaminophen/Codeine
After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit
Other Name: Tylenol 3

Detailed Description:

Primary Objective:

To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen).

Secondary Objective:

To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction.

Sixty-three patients enrolled for each group (non-opioid and opioid). Approximately 145 patients will be required to achieve complete data for 63 patients in each group (assuming 15% lost to follow-up & failure to comply with study protocol).

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients undergoing ambulatory hand surgery for carpal tunnel and trigger finger, under local anesthesia with or without sedation.

Exclusion Criteria:

  • ASA> 3;
  • Coagulopathy;
  • Renal disease,
  • Liver disease,
  • History of recent gastro-intestinal bleeding
  • Pregnancy.
  • Diagnosis of chronic pain currently taking opioid pain medication or with a history of drug abuse.
  • Patients with a self-described allergy to ASA, acetaminophen, NSAIDS and codeine.
  • All patients receiving a brachial plexus block for anesthesia and/or analgesia
  Contacts and Locations
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): NCT02647788


Contacts
Contact: Colleen E Pellegrini, BA (215) 294-9611 colleen.pellegrini@uphs.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Health System Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Colleen E Pellegrini, BA    215-294-9611    colleen.pellegrini@uphs.upenn.edu   
Principal Investigator: David Steinberg, MD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: David Steinberg, MD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02647788     History of Changes
Other Study ID Numbers: BACH-2015, 823043
First Submitted: January 4, 2016
First Posted: January 6, 2016
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Pennsylvania:
Pain, Postoperative

Additional relevant MeSH terms:
Acetaminophen
Ibuprofen
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Codeine
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
Antitussive Agents
Respiratory System Agents