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Hip Scope Fascia-iliaca (FI) Block Study

Primary Purpose

Hip Dysplasia, Femoroacetabular Impingement, Acetabular Labrum Tear

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ropivicaine
clonidine
Epinephrine
Noropin
Sponsored by
The Hawkins Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Dysplasia focused on measuring Hip Arthroscopy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FI Block

Local Injection

Arm Description

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 anesthetic in the hip joint consisting of 30cc of 0.5% Noropin

Outcomes

Primary Outcome Measures

Visual Analog Scale
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

Opioid Consumption
Opioid consumption, as measured by narcotic usage (morphine milligram equivalents)

Full Information

First Posted
February 4, 2015
Last Updated
February 20, 2019
Sponsor
The Hawkins Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02365961
Brief Title
Hip Scope Fascia-iliaca (FI) Block Study
Official Title
Reduction of Hip Arthroscopy Post-operative Pain Using Ultrasound-guided Fascia-iliaca Block
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hawkins Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Dysplasia, Femoroacetabular Impingement, Acetabular Labrum Tear
Keywords
Hip Arthroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FI Block
Arm Type
Experimental
Arm Description
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)
Arm Title
Local Injection
Arm Type
Active Comparator
Arm Description
Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin
Intervention Type
Drug
Intervention Name(s)
ropivicaine
Intervention Type
Drug
Intervention Name(s)
clonidine
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Intervention Type
Drug
Intervention Name(s)
Noropin
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Opioid Consumption
Description
Opioid consumption, as measured by narcotic usage (morphine milligram equivalents)
Time Frame
3 Months
Other Pre-specified Outcome Measures:
Title
Time in PACU
Description
Measured time subjects spent in the post anesthesia care unit.
Time Frame
Duration of PACU stay in minutes from end of surgery to discharge from PACA
Title
Total Number of Episodes of Nausea and Vomiting
Description
Occurrences of periods of nausea and vomiting
Time Frame
From end of surgery to discharge from PACU
Title
Hospital Readmission
Description
Number of participants that were readmitted to the hospital
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Kim, MD
Organizational Affiliation
Greenville Anesthesiology - Greenville Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31999469
Citation
Glomset JL, Kim E, Tokish JM, Renfro SD, Seckel TB, Adams KJ, Folk J. Reduction of Postoperative Hip Arthroscopy Pain With an Ultrasound-Guided Fascia Iliaca Block: A Prospective Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(3):682-688. doi: 10.1177/0363546519898205. Epub 2020 Jan 30.
Results Reference
derived

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Hip Scope Fascia-iliaca (FI) Block Study

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