Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries

April 3, 2018 updated by: John Fowler

Comparing Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol Administration for Carpal Tunnel Release and Distal Radius Fracture Surgeries

The purpose of this study is to determine the efficacy of intra-operative administration of IV tylenol and/or IV toradol in minimizing post-operative pain for carpal tunnel patients and distal radius fracture patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study population will include patients presenting for surgery with carpal tunnel syndrome as well as surgical treatment of distal radius fracture. Patients will be treated intra-operatively with either IV tylenol, IV toradol, both, or neither. All patients will receive the standard post-operative prescriptions for pain management. Daily pain surveys scoring pain from 0-10 will be distributed to the subjects to be filled out over the course of 10 days prior to first post-operative visit, usually 10-14 days later. Number of pain pills used before the first post-operative visit will also be measured.

We hypothesize that the effects of intra-operative administration of IV tylenol and/or IV toradol will have a significant effect on decreasing post-operative pain in the first 10 days following distal radius fracture surgeries, with a significant difference in pain described as at least a 2 points on a 0-10 pain scale.

We also hypothesize that intra-operative administration of IV tylenol and/or IV toradol will not have such significant effect on decreasing post-operative pain for carpal tunnel release surgery.

A secondary aim is to evaluate the post-operative opioid consumption of patients within these treatment groups. We hypothesize that opioid consumption will be decreased in the groups receiving IV tylenol and/or toradol for distal radius fracture surgery compared to the placebo group. We do not expect such a difference for the carpal tunnel release surgery group.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Kaufmann Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • carpal tunnel release surgery candidates,
  • distal radius fracture surgery candidates

Exclusion Criteria:

  • under 18 years of age,
  • pregnant women,
  • prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IV tylenol
One time intra-operative IV acetaminophen administration
Drug: Acetaminophen
Other Names:
  • tylenol
Experimental: IV toradol
One time intra-operative IV ketorolac thromethamine administration
Drug: Ketorolac Tromethamine
Other Names:
  • toradol
Experimental: IV tylenol/toradol combination
One time intra-operative IV combination of acetaminophen/ketorolac administration
Drug: Acetaminophen
Other Names:
  • tylenol
Drug: Ketorolac Tromethamine
Other Names:
  • toradol
Placebo Comparator: saline
One time intra-operative 50ml IV normal saline administration
Drug: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain (Pain Scores From 0-10 Scale)
Time Frame: 7 days
This is an ordinal pain scale. The patient picks a number from 0-10 scale every 4 hours for 7 days post-operatively. 0 is no pain, 10 is the worst pain imaginable. Lower scores would be preferable to higher scores.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption (Number of Pills Taken)
Time Frame: 7 days

Daily opioid consumption assessed as number of pills taken that day, each day for 7 days post-operatively

Outcome measure reported below is mean number of opioid pills consumed per day.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Fowler

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (Estimate)

December 10, 2014

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO14110464

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Clinical Trials on Saline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe