Study of the QUadratus Lumborum Bloc in Total Hip ARthroplasty: Efficacy and Safety (SQUARE)

The purpose of this prospective research study is to determine the best way to manage post-operative pain after a total hip arthroplasty. Currently, there is no standard of care for managing post-operative pain in these patients. The quadratus lumborum block (QLB) first described by Blanco in 2007, is a promising technique in this indication: recently, there is a growing evidence for the use of the QLB as an alternative technique for pain management after hip surgery.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Total Hip Replacement
• Intervention / Treatment: Procedure: posterior Quadratus Lumborum Block (QLB)

Detailed Description

A sample size of 100 patients (50 per group) was calculated based on 20% reduction in morphine consumption with 0.05% significance and a power of 0.8.

After ethical committee approval, eligible patients scheduled to have a fast-track total hip arthroplasty are screened during preoperative evaluation clinic. Informed written consent will be obtained from all patients during pre-anesthesia visit the day before surgery (J-1). Consenting patients will be randomized the day of surgery (J0) to undergo QLB with ropivacaine ("ropivacaine group") or normal saline ("saline group").

Before general anesthesia, all patients will have a needle-insertion posterior to the quadratus lumborum muscle avec injection of either ropivacaine in the "ropivacaine group" or normal saline in the "saline group".

After general anesthesia induction, dexamethasone and ketamine will be given to all patients.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Occitanie
    • Montpellier, Occitanie, France, 34934
      • Lapeyronie Teaching Hospital Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anesthesiologists Physical Classification Status (ASA) I to III
• Age ≥ 18 years
• Scheduled for fast-track total hip arthroplasty
• Written informed consent
• Patient covered by health insurance Exclusion Criteria
• Protected patients or patients incapable of giving written informed consent
• Pregnant or breastfeeding woman
• Vulnerable adult
• Contraindication for fast-track surgery
• Inability to comprehend or participate in pain scoring scales
• Allergy to study drugs
• Severe coagulopathy
• Chronic kidney disease with glomerular filtration rate (GFR) ≤ 30 mL/min (estimated by the Cockcroft & Gault formula)
• Chronic pain (treated by nonsteroidal anti-inflammatory drugs, opioids, neuroleptic drugs, antidepressant or anticonvulsants)
• Peripheral neuropathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ropivacaine; Active Comparator: ropivacaine group - Before general anaesthesia, ultrasound guided Quadratus Lumborum Block (QLB) will be performed with 30 mL 0.33% Ropivacaine	Procedure: posterior Quadratus Lumborum Block (QLB); Procedure (experimental): ultrasound guided posterior Quadratus Lumborum Block (QLB) Procedure (experimental): Sham Block
Placebo Comparator: placebo; Sham Comparator: saline group - Before general anaesthesia, ultrasound guided Sham Quadratus Lumborum Block (QLB) will be performed with 30 mL saline.	Procedure: posterior Quadratus Lumborum Block (QLB); Procedure (experimental): ultrasound guided posterior Quadratus Lumborum Block (QLB) Procedure (experimental): Sham Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of the posterior quadratus lumborum block (QLB) versus placebo on morphine consumption during the first 24 hours after a total hip arthroplasty	the first 24 hours after a total hip arthroplasty

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Philippe BIBOULET, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2017
• Primary Completion (Actual): September 10, 2018
• Study Completion (Actual): September 10, 2018

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 9798 (Fred Hutch/University of Washington Cancer Consortium)

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.: No