NCT02647788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 18, 2019

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

2.1 years

First QC Date

January 4, 2016

Results QC Date

January 18, 2019

Last Update Submit

February 12, 2019

Conditions

Pain, Postoperative

Keywords

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Quality of Recovery-9 (QoR-9).

    Postoperative Day 2

  • Number of Pills Used

    From the time of surgery to first clinic visit (post-op day 6 to 8)

Study Arms (2)

Acetaminophen/Ibuprofen

ACTIVE COMPARATOR

Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg

Drug: Acetaminophen/Ibuprofen

Acetaminophen/Codeine

ACTIVE COMPARATOR

Group 2: Acetaminophen 300mg, Codeine 30 mg

Drug: Acetaminophen/Codeine

Interventions

Acetaminophen/IbuprofenDRUG

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

Also known as: Tylenol/Advil
Acetaminophen/Ibuprofen
Acetaminophen/CodeineDRUG

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

Also known as: Tylenol 3
Acetaminophen/Codeine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing ambulatory hand surgery for carpal tunnel and trigger finger, under local anesthesia with or without sedation.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

AcetaminophenIbuprofenacetaminophen, codeine drug combination

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Results Point of Contact

Title
Dr. Benjamin Gray
Organization
University of Pennsylvania
Benjamin.Gray@uphs.upenn.edu
215-294-9650

Study Officials

  • David Steinberg, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 6, 2016

Study Start

December 1, 2015

Primary Completion

January 19, 2018

Study Completion

January 19, 2018

Last Updated

February 18, 2019

Results First Posted

February 18, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)