CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 88 enrolled
Drug / intervention
0.5% ropivacaine +1 moredrug
Likely dose
0.5% ropivacaine 3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04860856
NCT04860856Phase 4Completed
CompareCT.gov

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

University of Cincinnati·interventional·Posted Apr 27, 2021·Updated Feb 16, 2023

In Brief

A Phase 4 clinical trial evaluating 0.5% ropivacaine and Normal Saline for Femur Fracture. Completed, enrolled 88 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFemur Fracture
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedApr 27, 2021
Enrollment StartAug 17, 2019
Primary CompletionFeb 7, 2023
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 5.2 years ago

Interventions

0.5% ropivacainedrug

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.

Normal Salinedrug

20ml of normal saline