Quadratus Lumborum Block for Total Hip Arthroplasty

Quadratus Lumborum (QL) Nerve Block for Patients Undergoing Primary Total Hip Arthroplasty (THA)

The quadratus lumborum (QL) block is a fascial plane block that has been described to provide analgesia from T7-L3 dermatomes. The investigators aim to evaluate the efficacy of QL blocks in patients undergoing primary total hip arthroplasty (THA).

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Active Comparator; Drug: Placebo Comparator

Detailed Description

Investigators will enroll subjects planned for primary THA and allocate them into receiving a QL block with either saline or ropivacaine. Primary outcome will be pain scores over the first 48 hours after surgery.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jennifer Scovotti, MA; Phone Number: 310-206-4484; Email: jscovotti@mednet.ucla.edu
• Study Contact Backup: Name: Pamela Chia, MD; Phone Number: 310-267-83217; Email: pchia@mednet.ucla.edu

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Recruiting
      • UCLA Medical Center, Santa Monica
      • Contact: Jennifer Scovotti, MA; Phone Number: 310-206-4484; Email: jscovotti@mednet.ucla.edu
      • Contact: Pamela Chia, MD; Phone Number: 310-267-3217; Email: pchia@mednet.ucla.edu
      • Principal Investigator: Pamela Chia, MD
      • Sub-Investigator: Alexandra Stavrakis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult subjects undergoing elective primary total hip arthroplasty

Exclusion Criteria:

• patients age < 18,
• documented allergy to local anesthetic
• presence of peripheral neuropathy
• patients with current long term opioid use defined as receiving an opioid on most days in a 90 day period
• patients with a contraindication to spinal and regional anesthesia such as coagulopathy or infection at the site of the regional technique.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group; Quadratus lumborum nerve block with 0.25% ropivacaine	Drug: Active Comparator; QL block with 0.25% ropivacaine
Placebo Comparator: Control Group; Quadratus lumborum nerve block with saline	Drug: Placebo Comparator; QL block with saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain scores will be assessed over 48hrs postop using the visual analog score	Up to 48 hrs post op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid usage	Total morphine-equivalent will be calculated at 0-24hrs and 24-48hrs postop.	Up to 48 hrs post op
Time to first stand	The period between the end of surgery and the patient's first successful attempt at standing, with or without the assistance of devices (i.e. walker, cane) or staff assistance.	Up to 1 week post surgery
Time to first ambulation	Time to first ambulation of 50 feet or more, with or without the help of assist devices (i.e. walker, cane) or staff assistance.	Up to 1 week post surgery
Ambulation distance	This data point will be measured in feet and will be determined by the distance ambulated during the patient's first ambulation attempt after surgery, regardless of the length of ambulation (This distance will be counted regardless of whether the patient reaches the 50 feet requirement to be counted as the "time to first ambulation).	Up to 1 week post surgery
Length of hospital stay	Number of days in the hospital from postoperative day 0 to discharge	Until discharge from hospital, up to 1 week post surgery
Patient satisfaction	Patient satisfaction score will be assessed on day of discharge as measured by a 5-point scale with 1 = terrible, 2 = poor, 3 = satisfactory, 4 = good, and 5 = excellent.	Until day of discharge from the hospital, up to 1 week post surgery

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Pamela Chia, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: January 30, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 16, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: quadratus lumborum nerve block, analgesia, total hip arthroplasty, postoperative outcomes
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 21-001850

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes