Evaluating the Efficacy of Erector Spinae Block in Routine Hip Arthroscopy

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04917510
• Other study ID #: IRB-21-1223
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2021
• Est. completion date: August 2023

Study information

• Verified date: June 2021
• Source: Carilion Clinic
• Contact: Benjamin Coobs, MD
• Phone: (540) 521-3830
• Email: brcoobs[@]carilionclinic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Disease
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Erector spinae block
See experimental arm group description
• Local block
See control and study arm group descriptions for the local block

Locations

Country	Name	City	State
United States	Institute for Orthopedics and Neurosciences	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Carilion Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Anesthesia Care Unit Opioids	Total morphine milligram equivalents of administered in the post-operative care unit	6 hours post-operatively
Primary	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	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
Secondary	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
Secondary	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
Secondary	Outpatient Opioids	Opioids consumed after discharge from hospital	4 weeks post discharge
Secondary	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