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

Use our guide to learn which trials are right for you!

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.

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).

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
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials