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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647788
• Other study ID #: BACH-2015, 823043
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: January 19, 2018

Study information

• Verified date: February 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 19, 2018
• Est. primary completion date: January 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Acetaminophen/Ibuprofen
After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit
• Acetaminophen/Codeine
After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	Postoperative Day 2
Secondary	Number of Pills Used		From the time of surgery to first clinic visit (post-op day 6 to 8)