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Iliac Fascia Block (Ropivacaine) for Hip Injury

Phase 4

Waitlist Available

Led By Blake Bodendorfer, MD

Research Sponsored by Georgetown University

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks and 6 weeks

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

Summary

The purpose of this research is to determine differences in outcomes in patients who do, or do not, receive regional anesthesia (a fascia iliaca block) prior to undergoing hip arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement

Eligible Conditions

Hip Injury

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks and 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks and 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain Medication Requirement in PACU

Secondary study objectives

Duration of PACU stay (mins)

Falls

Long Term Medication Requirements (daily log of medication usage in tablets of 5 mg oxycodone, morphine extended relief 15 mg, and/or indomethacin 75 mg)

+6 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Iliac Fascia Block (Ropivacaine)Experimental Treatment2 Interventions

These patients will receive a preoperative iliac fascia block performed as a single shot in the standard fashion prior to hip arthroscopy with general anesthesia.

Group II: Control (Normal Saline Sham Injection)Placebo Group2 Interventions

These patients will receive a preoperative sham block of normal saline in the same fashion as a standard singl shot iliac fascia block prior to hip arthroscopy with general anesthesia.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ropivacaine

FDA approved

General Anesthesia

2014

Completed Phase 4

~7010

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