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Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures

NCT02967172 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-12-15

Study results available
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Summary

The purpose of this study is to determine the efficacy and safety of a peri-articular multimodal injection for post-operative pain control following operative management of closed, rotational ankle fractures. Enrolled subjects will be randomized to either receive or not receive intra-operative injections in addition to standard opioid analgesic regimens. Patients will be treated with standard of care surgical techniques by the treating orthopaedic surgeon for the patient's specific fracture pattern. The patients randomized into the injection cohort will receive a 25cc intra-operative injection with 200 mg ropivacaine, 0.6 mg epinephrine, 5 mg and morphine into the local superficial and deep peri-incisional tissues while under general anesthesia. Total post-operative opioid consumption expressed in morphine equivalent dose will be recorded, including IV and oral opioids. Time in hours from operation conclusion to discharge and discharge disposition (to where the patient is discharged) will also be recorded. Post-operative pain scores will be assessed and recorded in the immediate post-operative period and every 4 hours subsequently until the patient is discharged. Medication related side effects will be monitored. The investigators hypothesize that the injection cohort will have reduced pain scores, lower narcotic requirements, shorter length of stay, and be more likely to discharge to home following surgery.

Conditions

  • Pain, Postoperative
  • Ankle Fractures

Interventions

DRUG

Ropivacaine

DRUG

Epinephrine

DRUG

Morphine

DRUG

0.9% sodium chloride solution

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Principal Investigators

  • Kyle Hancock, MD · Resident Physician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-09-21
Completion
2018-09-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02967172 on ClinicalTrials.gov