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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT03189290

Collaborator

(none)

100

Enrollment

Location

Arms

14.2

Actual Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Total Hip Replacement	Procedure: posterior Quadratus Lumborum Block (QLB)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 6, 2017

Actual Primary Completion Date :

Sep 10, 2018

Actual Study Completion Date :

Sep 10, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lapeyronie Teaching Hospital Montpellier	Montpellier	Occitanie	France	34934

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

Principal Investigator: Philippe BIBOULET, MD, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT03189290

Other Study ID Numbers:

9798

First Posted:

Jun 16, 2017

Last Update Posted:

Apr 22, 2019

Last Verified:

Apr 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Apr 22, 2019