Evaluating the Efficacy of Erector Spinae Block in Routine Hip Arthroscopy

NCT04917510 | Unknown

• 1 other identifier: IRB-21-1223
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Disease; Postoperative Pain

Keywords

Hip; Pain; Arthroscopy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Hip disability and Osteoarthritis Outcome Score

  1 year post-operatively

• Patient Reported Outcomes measurement Information System Score

  1 year post-operatively

• Range Of Motion

  1 year post-operatively

• Outpatient Opioids

  4 weeks post discharge

• Outpatient Visual Analog Scale scores

  4 weeks post discharge

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Study

EXPERIMENTAL

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: Erector spinae block; Procedure: Local block

Interventions

Erector spinae block PROCEDURE

See experimental arm group description

Study

Local block PROCEDURE

See control and study arm group descriptions for the local block

Control; Study

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Institute for Orthopedics and Neurosciences

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Benjamin Coobs, MD

  Carilion Clinic Ortho Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Coobs, MD

CONTACT

(540) 521-3830; brcoobs@carilionclinic.org

Daniel Sveom

CONTACT

(540) 981-8050; dsveom@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Erector spinae block will be performed after general anesthesia has been induced. Patients will be unaware which arm of the study they are in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to either the study group or control group prior to undergoing surgery

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 8, 2021
• Study Start: July 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: June 8, 2021

Record last verified: 2021-06

Locations

US (1)