Evaluating the Efficacy of Erector Spinae Block in Routine Hip Arthroscopy

Evaluating the Efficacy of Erector Spinae Block in Routine Hip Arthroscopy: A Prospective Analysis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Hip Disease
• Intervention / Treatment: Procedure: Local block; Procedure: Erector spinae block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin Coobs, MD; Phone Number: (540) 521-3830; Email: brcoobs@carilionclinic.org
• Study Contact Backup: Name: Daniel Sveom; Phone Number: (540) 981-8050; Email: dsveom@carilionclinic.org

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Institute for Orthopedics and Neurosciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control; 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.	Procedure: Local block; See control and study arm group descriptions for the local block
EXPERIMENTAL: Study; 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.	Procedure: Local block; See control and study arm group descriptions for the local block; Procedure: Erector spinae block; See experimental arm group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Anesthesia Care Unit Opioids	Total morphine milligram equivalents of administered in the post-operative care unit	6 hours post-operatively
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	6 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year post-operatively
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	1 year post-operatively
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.	1 year post-operatively
Outpatient Opioids	Opioids consumed after discharge from hospital	4 weeks post discharge
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	4 weeks post discharge

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Investigators: Principal Investigator: Benjamin Coobs, MD, Carilion Clinic Ortho Surgeon

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (ACTUAL): June 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Hip; Arthroscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: IRB-21-1223

Drug and device information, study documents

• 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