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Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02647788
Recruitment Status : Completed
First Posted : January 6, 2016
Results First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE January 4, 2016
First Posted Date  ICMJE January 6, 2016
Results First Submitted Date  ICMJE January 18, 2019
Results First Posted Date  ICMJE February 18, 2019
Last Update Posted Date February 18, 2019
Study Start Date  ICMJE December 2015
Actual Primary Completion Date January 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score [ Time Frame: Subjects reported pain 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). The numbers reported are the average daily pain scores ]
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). The pain VAS is a continuous scale where 0=no pain and 10=worst pain imaginable.
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2016)
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
  • 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. This 9 question survey has a maximum score (best outcome) of 18 and minimum (worst outcome) of 3. The survey was administered over the phone on post-operative day 2.
  • Number of Pills Used [ Time Frame: From the time of surgery to first clinic visit (post-op day 6 to 8) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2016)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery
Official Title  ICMJE 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
Brief Summary 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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Acetaminophen/Ibuprofen
    Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg
    Intervention: Drug: Acetaminophen/Ibuprofen
  • Active Comparator: Acetaminophen/Codeine
    Group 2: Acetaminophen 300mg, Codeine 30 mg
    Intervention: Drug: Acetaminophen/Codeine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2019)
144
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2016)
126
Actual Study Completion Date  ICMJE January 19, 2018
Actual Primary Completion Date January 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02647788
Other Study ID Numbers  ICMJE BACH-2015, 823043
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Steinberg, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP