Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery
Status: | Completed |
---|---|
Conditions: | Post-Surgical Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/20/2019 |
Start Date: | December 2015 |
End Date: | January 19, 2018 |
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
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.
(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.
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).
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).
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
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
Principal Investigator: David Steinberg, MD
Phone: 215-294-9611
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