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Evaluating the Efficacy of Erector Spinae Block in Routine Hip Arthroscopy

Primary Purpose

Hip Disease, Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erector spinae block
Local block
Sponsored by
Carilion Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Disease focused on measuring Hip, Pain, Arthroscopy

Eligibility Criteria

13 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients undergoing hip arthroscopy for femoroacetabular impingement
  • Ages 13-50
  • Individuals who have the capacity to provide consent or assent for themselves

Exclusion Criteria:

  • Hip arthroscopy for any other reason (not undergoing labral repair, acetabuloplasty, and femoral osteochondroplasty)
  • Revision surgery
  • Known narcotic use in the 6 months prior to surgery
  • Workman's compensation patient
  • Pregnancy

Sites / Locations

  • Institute for Orthopedics and Neurosciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Study

Arm Description

Will not receive erector spinae block. Will be administered 30 mL of 0.5% Marcaine w/ epinephrine as a local block at the surgical site at the conclusion of the procedure.

Will receive an erector spinae block prior to surgery using 30-45 mL of 0.25 bupivacaine w/ epinephrine and 5 mL of dexmedetomidine. Will be administered 30 mL of 0.5% marcaine w/ epinephrine as a local block at the surgical site at the conclusion of the procedure.

Outcomes

Primary Outcome Measures

Post Anesthesia Care Unit Opioids
Total morphine milligram equivalents of administered in the post-operative care unit
Post Anesthesia Care Unit Pain
Visual analogue pain score at the time of discharge from the Post Anesthesia Care Unit in which 0 equals no pain and 10 equals extreme pain

Secondary Outcome Measures

Hip disability and Osteoarthritis Outcome Score
Hip disability and Osteoarthritis Outcome score at post-op visits in which 0 equals no pain and 100 equals unbearable pain
Patient Reported Outcomes measurement Information System Score
Patient Reported Outcomes measurement Information System score at post-op visits in which 0 equals no pain and 10 equals extreme pain
Range Of Motion
Hip range of motion in degrees of motion, will be examined by the operative surgeon in the office measured by flexion 0-110 degrees with 0 being no range of motion and 110 being full range of motion, internal rotation -5-25 degrees with -5 being no range of motion and -25 being full range of motion, and external rotation 0-60 degrees with 0 being no range of motion and 60 being full range of motion.
Outpatient Opioids
Opioids consumed after discharge from hospital
Outpatient Visual Analog Scale scores
Pain scores each day for the first 4 weeks after surgery on the Visual Analog Scale in which 0 equals no pain and 10 equals unbearable pain

Full Information

First Posted
May 28, 2021
Last Updated
June 4, 2021
Sponsor
Carilion Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04917510
Brief Title
Evaluating the Efficacy of Erector Spinae Block in Routine Hip Arthroscopy
Official Title
Evaluating the Efficacy of Erector Spinae Block in Routine Hip Arthroscopy: A Prospective Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carilion Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
The aim of this project is to evaluate the efficacy of preoperative erector spinae blocks in arthroscopic hip surgery. This will be a prospective randomized controlled trial.
Detailed Description
The aim of this project is to evaluate the efficacy of preoperative erector spinae blocks in arthroscopic hip surgery. This will be a prospective randomized controlled trial. The control group will not receive a preoperative block prior to surgery, but will receive local anesthetic at the surgical site at the conclusion of the surgery. The study group will receive a preoperative block and local anesthetic. The primary outcomes will be pain levels and opioid consumption in the post-operative care unit. The secondary outcomes will be pain levels and opioid consumption post-operatively, and functional outcome measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Disease, Postoperative Pain
Keywords
Hip, Pain, Arthroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to either the study group or control group prior to undergoing surgery
Masking
Participant
Masking Description
Erector spinae block will be performed after general anesthesia has been induced. Patients will be unaware which arm of the study they are in.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Will not receive erector spinae block. Will be administered 30 mL of 0.5% Marcaine w/ epinephrine as a local block at the surgical site at the conclusion of the procedure.
Arm Title
Study
Arm Type
Experimental
Arm Description
Will receive an erector spinae block prior to surgery using 30-45 mL of 0.25 bupivacaine w/ epinephrine and 5 mL of dexmedetomidine. Will be administered 30 mL of 0.5% marcaine w/ epinephrine as a local block at the surgical site at the conclusion of the procedure.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae block
Intervention Description
See experimental arm group description
Intervention Type
Procedure
Intervention Name(s)
Local block
Intervention Description
See control and study arm group descriptions for the local block
Primary Outcome Measure Information:
Title
Post Anesthesia Care Unit Opioids
Description
Total morphine milligram equivalents of administered in the post-operative care unit
Time Frame
6 hours post-operatively
Title
Post Anesthesia Care Unit Pain
Description
Visual analogue pain score at the time of discharge from the Post Anesthesia Care Unit in which 0 equals no pain and 10 equals extreme pain
Time Frame
6 hours post-operatively
Secondary Outcome Measure Information:
Title
Hip disability and Osteoarthritis Outcome Score
Description
Hip disability and Osteoarthritis Outcome score at post-op visits in which 0 equals no pain and 100 equals unbearable pain
Time Frame
1 year post-operatively
Title
Patient Reported Outcomes measurement Information System Score
Description
Patient Reported Outcomes measurement Information System score at post-op visits in which 0 equals no pain and 10 equals extreme pain
Time Frame
1 year post-operatively
Title
Range Of Motion
Description
Hip range of motion in degrees of motion, will be examined by the operative surgeon in the office measured by flexion 0-110 degrees with 0 being no range of motion and 110 being full range of motion, internal rotation -5-25 degrees with -5 being no range of motion and -25 being full range of motion, and external rotation 0-60 degrees with 0 being no range of motion and 60 being full range of motion.
Time Frame
1 year post-operatively
Title
Outpatient Opioids
Description
Opioids consumed after discharge from hospital
Time Frame
4 weeks post discharge
Title
Outpatient Visual Analog Scale scores
Description
Pain scores each day for the first 4 weeks after surgery on the Visual Analog Scale in which 0 equals no pain and 10 equals unbearable pain
Time Frame
4 weeks post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients undergoing hip arthroscopy for femoroacetabular impingement Ages 13-50 Individuals who have the capacity to provide consent or assent for themselves Exclusion Criteria: Hip arthroscopy for any other reason (not undergoing labral repair, acetabuloplasty, and femoral osteochondroplasty) Revision surgery Known narcotic use in the 6 months prior to surgery Workman's compensation patient Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Coobs, MD
Phone
(540) 521-3830
Email
brcoobs@carilionclinic.org
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Sveom
Phone
(540) 981-8050
Email
dsveom@carilionclinic.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Coobs, MD
Organizational Affiliation
Carilion Clinic Ortho Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Orthopedics and Neurosciences
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States

12. IPD Sharing Statement

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Evaluating the Efficacy of Erector Spinae Block in Routine Hip Arthroscopy

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