Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen/Ibuprofen
Acetaminophen/Codeine
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Pain, Postoperative
Eligibility 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
Sites / Locations
- University of Pennsylvania Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Acetaminophen/Ibuprofen
Acetaminophen/Codeine
Arm Description
Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg
Group 2: Acetaminophen 300mg, Codeine 30 mg
Outcomes
Primary Outcome Measures
Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score
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.
Secondary Outcome Measures
Quality of Recovery-9 (QoR-9).
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
Full Information
NCT ID
NCT02647788
First Posted
January 4, 2016
Last Updated
February 12, 2019
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02647788
Brief Title
Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 19, 2018 (Actual)
Study Completion Date
January 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acetaminophen/Ibuprofen
Arm Type
Active Comparator
Arm Description
Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg
Arm Title
Acetaminophen/Codeine
Arm Type
Active Comparator
Arm Description
Group 2: Acetaminophen 300mg, Codeine 30 mg
Intervention Type
Drug
Intervention Name(s)
Acetaminophen/Ibuprofen
Other Intervention Name(s)
Tylenol/Advil
Intervention Description
After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit
Intervention Type
Drug
Intervention Name(s)
Acetaminophen/Codeine
Other Intervention Name(s)
Tylenol 3
Intervention Description
After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit
Primary Outcome Measure Information:
Title
Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score
Description
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.
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
Secondary Outcome Measure Information:
Title
Quality of Recovery-9 (QoR-9).
Description
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.
Time Frame
Postoperative Day 2
Title
Number of Pills Used
Time Frame
From the time of surgery to first clinic visit (post-op day 6 to 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Steinberg, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery
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