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

NCT ID: NCT02647788

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-01-19

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).

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acetaminophen/Ibuprofen

Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg

Group Type: ACTIVE_COMPARATOR

Acetaminophen/Ibuprofen

Intervention Type: DRUG

After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit

Acetaminophen/Codeine

Group 2: Acetaminophen 300mg, Codeine 30 mg

Group Type: ACTIVE_COMPARATOR

Acetaminophen/Codeine

Intervention Type: DRUG

After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit

Interventions

Acetaminophen/Ibuprofen

After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit

Intervention Type: DRUG

Acetaminophen/Codeine

After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit

Intervention Type: DRUG

Other Intervention Names

Tylenol/Advil; Tylenol 3

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Steinberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BACH-2015, 823043

Identifier Type: -

Identifier Source: org_study_id