Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-06-05

Brief Summary

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This is a phase I, randomized, single-blind, placebo-controlled, single-center study of the effects of surgical site injection on pain and narcotic utilization in participants who undergo surgery for lower extremity fractures. 200 participants with lower extremity fractures who are admitted for operative fixation will be included in the study. Participants will be randomized to receive either a pain cocktail injection around the fracture site and surrounding tissues or control (no injection). An analysis of pain scores, rehabilitation progress, length of stay, narcotic utilization, and satisfaction scores will be performed.

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Detailed Description

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Conditions

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Pertrochanteric Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Spinal Anesthesia

Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.

Group Type EXPERIMENTAL

Marcaine, Duramorph , ketorolac

Intervention Type DRUG

Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.

Bupivacaine (Marcaine)

Intervention Type DRUG

0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.

General Anesthesia

The control group will receive no injection into area surrounding the fracture site

Group Type ACTIVE_COMPARATOR

General Anesthetics

Intervention Type DRUG

Placebo group will only receive standard of care general anesthesia

Interventions

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Marcaine, Duramorph , ketorolac

Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.

Intervention Type DRUG

Bupivacaine (Marcaine)

0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.

Intervention Type DRUG

General Anesthetics

Placebo group will only receive standard of care general anesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Lower extremity fracture including femoral neck, intertrochanteric, sub-trochanteric, and femoral shaft fracture

Exclusion Criteria

* Pregnant women
* Treatment with Arthroplasty
* Patients who receive a peripheral nerve block
* Patients who receive intra-op or post-op ketamine
* Patients with concomitant TBI or MR
* Polytrauma patients
* Pathologic Fractures
* Patients who live greater than 10 miles from NYU or who will not be followed by an NYU provider
* Patients with a contraindication to any of the medications on the study list due to other medical problems such as renal or liver disease or due to allergy/intolerance
* Patients with prior extremity weakness resulting from stroke or other neurological condition
* Prior or current history of narcotic use
* Patients with advanced dementia
* NYUMC Students, Residents, Faculty

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No