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0.5% ropivacaine for Femur Fractures

Phase 4

Waitlist Available

Led By He C S, MD

Research Sponsored by University of Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at 0, 8, 16, 24, 36, 48, and 72 hours postoperatively

Awards & highlights

Study Summary

This trial is testing whether a pain-blocking injection during surgery can help control pain better than a saline solution injection in people with broken femurs.

Eligible Conditions

Femur Fracture

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 0, 8, 16, 24, 36, 48, and 72 hours postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at 0, 8, 16, 24, 36, 48, and 72 hours postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 0, 8, 16, 24, 36, 48, and 72 hours postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in postoperative pain at 72 hours

Secondary outcome measures

Narcotic usage

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Hematoma blockExperimental Treatment1 Intervention

Fracture site injection of 20 mL of 0.5% ropivacaine with an 18-gauge needle (150 mm length).

Group II: Normal saline injectionPlacebo Group1 Intervention

Fracture site injection of 20ml of normal saline.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ropivacaine

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor

427 Previous Clinical Trials

634,274 Total Patients Enrolled

He C S, MDPrincipal InvestigatorUniversity of Cincinnati

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollments being taken for this scientific investigation?

"Confirmed, this clinical trial is open to new patients. It was initially listed on August 17th 2019 and the last edit occurred 2nd of July 2021 according to information available on clinicaltrials.gov"

Answered by AI

Has the Food and Drug Administration given authorization for 0.5% ropivacaine?

"Our team has deemed that 0.5% ropivacaine is safe, scoring it a 3 on our scale due to this treatment having the stamp of approval from Phase 4 trials."

Answered by AI

How many participants have been recruited for this research endeavor?

"Affirmative. Clinicaltrials.gov displays evidence that this trial, which was originally launched on August 17th 2019, is now seeking participants to enrol in the study. A total of 88 individuals are needed for testing at a single clinical site."

Answered by AI

What medical application is 0.5% ropivacaine typically prescribed for?

"0.5% ropivacaine is a powerful anesthetic solution to administer during surgical anesthesia, labour, and other procedures that require general analgesia."

Answered by AI

Recent research and studies

Journal of Pediatric OrthopaedicsJournal

Hematoma Block Reduces Narcotic Pain Medication After Femoral Elastic Nailing in Children

Herrera, Jos?? A., Eric J. Wall, and Susan L. Foad. 2004. “Hematoma Block Reduces Narcotic Pain Medication After Femoral Elastic Nailing in Children”. Journal of Pediatric Orthopaedics. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00004694-200405000-00003.

Veterinary Anaesthesia and AnalgesiaJournal

Effect of Intrafragmentary Bupivacaine (haematoma Block) on Analgesic Requirements in Dogs Undergoing Fracture Repair

Dimopoulou, Irene, Tilemahos L. Anagnostou, Nikitas N. Prassinos, Ioannis Savvas, and Michael Patsikas. 2017. “Effect of Intrafragmentary Bupivacaine (haematoma Block) on Analgesic Requirements in Dogs Undergoing Fracture Repair”. Veterinary Anaesthesia and Analgesia. Elsevier BV. doi:10.1016/j.vaa.2017.01.005.

Journal of Bone and Joint SurgeryJournal

Efficacy of Surgical-site, Multimodal Drug Injection Following Operative Management of Femoral Fractures

Koehler, Daniel, J. Lawrence Marsh, Matthew Karam, Catherine Fruehling, and Michael Willey. 2017. “Efficacy of Surgical-site, Multimodal Drug Injection Following Operative Management of Femoral Fractures”. Journal of Bone and Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.16.00733.

Annals of Emergency MedicineJournal