Hip Scope Fascia-iliaca (FI) Block Study

Phase 4

Completed

• Conditions: Acetabular Labrum Tear; Hip Dysplasia; Femoroacetabular Impingement
• Interventions: Drug: ropivicaine; Drug: Noropin; Drug: clonidine; Drug: Epinephrine

• Registration Number: NCT02365961
• Lead Sponsor: The Hawkins Foundation

Brief Summary

Patients undergoing a hip scope procedure will be recruited for this study. They will be randomized to either receive a nerve block or no nerve block (pain medicine only). Pain levels and clinical outcomes will be assessed through 3 months post-operatively.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-11
• Study First Posted: 2015-02-19
• Study Start: 2015-04
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Results First Submitted: 2018-10-31
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-20
• Last Update Submitted: 2019-02-20
• Results First Posted: 2019-03-14
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Scheduled for outpatient hip arthroscopy
• American Society of Anesthesiologists (ASA) 1-3

Exclusion Criteria

• Prior surgery on ipsilateral hip
• ASA 4-6
• Chronic narcotic usage over 6 months or more than the equivalent of 20mg of morphine per day
• Current or prior placement of a spinal cord stimulator or intrathecal pump for pain control purposes
• Allergy to amide local anesthetics
• Contraindication to regional anesthesia
• BMI > 40
• Females who are pregnant or plan to get pregnant during the course of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FI Block	ropivicaine	Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \[per 60 mL\] and epinephrine 1:400,000)
FI Block	clonidine	Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \[per 60 mL\] and epinephrine 1:400,000)
FI Block	Epinephrine	Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \[per 60 mL\] and epinephrine 1:400,000)
Local Injection	Noropin	Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	3 Months	Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale.

Secondary Outcome Measures

Name	Time	Method
Opioid Consumption	3 Months	Opioid consumption, as measured by narcotic usage (morphine milligram equivalents)

Trial Locations

Locations (1)

Steadman Hawkins Clinic of the Carolinas - Greenville Health System; 🇺🇸 Greenville, South Carolina, United States