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

February 14, 2023 updated by: Ruixian Yue, University of Cincinnati
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This blinded, randomized control trial is being performed at the University of Cincinnati Medical Center.

Patients will be randomly assigned to one of two treatment groups: Group One will be comprised of patients treated with fracture site injection containing 20 mL of 0.5% ropivacaine with an 18-gauge needle (150 mm length), Group Two will be comprised of patients treated with fracture site injection containing 20ml of normal saline. The injection will be administered by the orthopaedic trauma team after the insertion of the final intramedullary implant and skin closure prior to final surgical dressing application. The injection will be performed in a standard fashion with aspiration of hematoma followed by the injection. All postoperative management will be per standard of care.

The size of the hematoma will have no effect on the procedure. When a hematoma block is utilized in the care of orthopaedic trauma patients, its aim is to infiltrate the anesthetic to the fracture edges and injured soft tissue to allow for pain control and fracture manipulation without additional sedation. Aspiration of the hematoma tells the clinician that the tip of the needle is near the fracture site and not in a neurovascular structure.

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.

Regional anesthesia including nerve blocks is not routinely used in the setting of traumatic femoral shaft fractures. A nerve block would compromise the patient's neurologic examination in the immediate postoperative period.

Randomization will be performed via Microsoft Excel to generate random numbers. Allocation will be concealed and revealed to the surgical team in the hour prior to the procedure. The patients and the nursing staff who assess postoperative pain will be blinded to the treatment allocation.

An a priori power analysis was performed to determine the sample size for the primary outcome measure. Prior literature has indicated that a difference of 1.3 on a VAS is clinically significant.5 Therefore, it was determined that a total of 44 patients were necessary per group to detect a 1.5-point difference on the VAS (power = 80%, p = 0.05).

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Trauma patient at the University of Cincinnati Medical Center
  • Skeletally mature patients
  • Have an isolated, closed, acute traumatic femoral shaft fracture to be treated with a closed reduction and reamed intramedullary rod fixation

Exclusion Criteria:

  • Unable to provide informed consent
  • Member of a vulnerable patient population
  • Have additional injuries
  • Have a history of prior existing narcotic use or chronic pain management issues on presentation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hematoma block
Fracture site injection of 20 mL of 0.5% ropivacaine with an 18-gauge needle (150 mm length).
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.
Placebo Comparator: Normal saline injection
Fracture site injection of 20ml of normal saline.
Drug: Normal Saline
20ml of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in postoperative pain at 72 hours
Time Frame: Measured at 0, 8, 16, 24, 36, 48, and 72 hours postoperatively
Postoperative pain will be assessed using a visual analog scale
Measured at 0, 8, 16, 24, 36, 48, and 72 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic usage
Time Frame: Narcotic usage will be assessed through 72 hours postoperatively
Oral morphine equivalents will be recorded
Narcotic usage will be assessed through 72 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Investigators

  • Principal Investigator: He C S, MD, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2019

Primary Completion (Actual)

February 7, 2023

Study Completion (Actual)

February 7, 2023

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OS19011 IRB 2019-0366

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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