Quadratus Lumborum Block for Analgesia Following Hip Arthroscopy

NCT03557125 | Completed Results DMC

• 1 other identifier: Pro00076191
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate difference in postoperative opiate consumption when patients do or do not receive a quadratus lumborum block preoperatively for hip arthroscopy.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  opioid consumption including intraoperative consumption exceeding 100µg of fentanyl and all postoperative opioid consumption in the postoperative anesthesia care unit (PACU).

  24 hours

Secondary Outcomes (6)

• Visual Analog Pain

  Immediately Post Operatively

• Visual Analog Scale at Time of Post Anesthesia Care Unit Discharge

  2 hours

• Post Anesthesia Care Unit Duration

  2 hours

• Patient Satisfaction

  24 hours

• Opioid Related Side Effects

  24 hours

Study Arms (2)

Receives QL Block

ACTIVE COMPARATOR

If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.

Other: QL Block

Receives Saline Skin Wheel No Block

PLACEBO COMPARATOR

The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.

Other: Saline Skin Wheel

Interventions

QL Block OTHER

If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.

Receives QL Block

Saline Skin Wheel OTHER

The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.

Receives Saline Skin Wheel No Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years-old

You may not qualify if:

• Local anesthetic allergy
• Chlorhexidine allergy
• Patient weight \< 40kg
• Patient is currently pregnant
• Patient is unable or chooses not to give informed consent
• Emergency surgery
• Known preoperative substance abuse
• Preoperative opioid use for over three months

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Results Point of Contact

• Title: Sylvia Wilson, MD
• Organization: Medical University of South Carolina

wilsonsh@musc.edu

843-792-2322

Study Officials

• Sylvia H Wilson, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Following informed consent, all patients will be positioned, prepped and sedated for a quadratus lumborum block in the preoperative holding area to blind the patient, surgeon, intraoperative anesthesia team and data collectors. The patient will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patient will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point. If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 14, 2018
• Study Start: May 22, 2018
• Primary Completion: March 13, 2020
• Study Completion: March 14, 2020
• Last Updated: February 2, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-01

Locations

US (1)