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

John Fowler

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Carpal Tunnel Release; Distal Radius Fracture

Treatments: Drug: Acetaminophen; Drug: Saline; Drug: Ketorolac Tromethamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02313675

PRO14110464

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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44 participants in 4 patient groups, including a placebo group

IV tylenol

Experimental group

Description:

One time intra-operative IV acetaminophen administration

Treatment:

Drug: Acetaminophen

IV toradol

Experimental group

Description:

One time intra-operative IV ketorolac thromethamine administration

Treatment:

Drug: Ketorolac Tromethamine

IV tylenol/toradol combination

Experimental group

Description:

One time intra-operative IV combination of acetaminophen/ketorolac administration

Treatment:

Drug: Ketorolac Tromethamine

Drug: Acetaminophen

saline

Placebo Comparator group

Description:

One time intra-operative 50ml IV normal saline administration

Treatment:

Drug: Saline