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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Pain, Carpal Tunnel Release, Distal Radius Fracture

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: Ketorolac Tromethamine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: carpal tunnel release surgery candidates, distal radius fracture surgery candidates Exclusion Criteria: under 18 years of age, pregnant women, prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV tylenol<br>One time intra-operative IV acetaminophen administration | Drug: Acetaminophen<br> <br> * Other names: tylenol;|
| Experimental: IV toradol<br>One time intra-operative IV ketorolac thromethamine administration | Drug: Ketorolac Tromethamine<br> <br> * Other names: toradol;|
| Experimental: IV tylenol/toradol combination<br>One time intra-operative IV combination of acetaminophen/ketorolac administration | Drug: Acetaminophen<br> <br> * Other names: tylenol;Drug: Ketorolac Tromethamine<br> <br> * Other names: toradol;|
| Placebo Comparator: saline<br>One time intra-operative 50ml IV normal saline administration | Drug: Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain (Pain Scores From 0-10 Scale) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carpal tunnel syndrome, opioid analgesics, postoperative pain, IV tylenol, IV toradol