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Efficacy of Hematoma Block on Postoperative Pain After Femoral Intramedullary Rodding: A Randomized Trial

NCT04860856 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2023-02-16

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of an intra-operative, post-fixation fracture hematoma block compared to saline control on postoperative pain control in patients with acute femoral shaft fractures. Our primary outcome measure is visual analog scale (VAS) pain scores which are recorded at regular intervals.

Conditions

  • Femur Fracture

Interventions

DRUG

0.5% ropivacaine

The maximal single dose of ropivacaine without vasoconstrictor is 2-3 mg/kg.9 0.5% ropivacaine has 5 mg/mL of ropivacaine. 20 mL of 0.5% ropivacaine has 100 mg of ropivacaine. 100 mg of ropivacaine can be toxic to a patient less than 33-50 kg or 73-110 lb. If a patient weighs less than 110 lb, the ropivacaine dose will be scaled down below 2 mg/kg.

DRUG

Normal Saline

20ml of normal saline

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • He C S, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-17
Primary Completion
2023-02-07
Completion
2023-02-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04860856 on ClinicalTrials.gov