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

University of Pennsylvania

Status and phase

Completed

Phase 4

Conditions

Pain, Postoperative

Treatments

Drug: Acetaminophen/Ibuprofen

Drug: Acetaminophen/Codeine

Study type

Interventional

Funder types

Other

Identifiers

NCT02647788

BACH-2015, 823043

Details and patient eligibility

About

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.

Full 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).

Enrollment

144 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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