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

Phase 4

Completed

Conditions: Postoperative Pain
Carpal Tunnel Release
Distal Radius Fracture

Interventions: Drug: Acetaminophen
Drug: Ketorolac Tromethamine
Drug: Saline

Registration Number: NCT02313675

Lead Sponsor: John Fowler

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

Inclusion Criteria

carpal tunnel release surgery candidates,
distal radius fracture surgery candidates

Exclusion Criteria

under 18 years of age,
pregnant women,
prisoners

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
IV tylenol	Acetaminophen	One time intra-operative IV acetaminophen administration
IV toradol	Ketorolac Tromethamine	One time intra-operative IV ketorolac thromethamine administration
IV tylenol/toradol combination	Acetaminophen	One time intra-operative IV combination of acetaminophen/ketorolac administration
IV tylenol/toradol combination	Ketorolac Tromethamine	One time intra-operative IV combination of acetaminophen/ketorolac administration
saline	Saline	One time intra-operative 50ml IV normal saline administration

Primary Outcome Measures

Name	Time	Method
Postoperative Pain (Pain Scores From 0-10 Scale)	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.

Secondary Outcome Measures

Name	Time	Method
Opioid Consumption (Number of Pills Taken)	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.