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

Primary Purpose

Postoperative Pain, Total Hip Replacement

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
posterior Quadratus Lumborum Block (QLB)
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lapeyronie Teaching Hospital Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ropivacaine

placebo

Arm Description

Active Comparator: ropivacaine group - Before general anaesthesia, ultrasound guided Quadratus Lumborum Block (QLB) will be performed with 30 mL 0.33% Ropivacaine

Sham Comparator: saline group - Before general anaesthesia, ultrasound guided Sham Quadratus Lumborum Block (QLB) will be performed with 30 mL saline.

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
May 5, 2017
Last Updated
April 19, 2019
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03189290
Brief Title
Study of the QUadratus Lumborum Bloc in Total Hip ARthroplasty: Efficacy and Safety
Acronym
SQUARE
Official Title
Study of the QUadratus Lumborum Bloc in Total Hip ARthroplasty: Efficacy and Safety
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 6, 2017 (Actual)
Primary Completion Date
September 10, 2018 (Actual)
Study Completion Date
September 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Total Hip Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ropivacaine
Arm Type
Active Comparator
Arm Description
Active Comparator: ropivacaine group - Before general anaesthesia, ultrasound guided Quadratus Lumborum Block (QLB) will be performed with 30 mL 0.33% Ropivacaine
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Sham Comparator: saline group - Before general anaesthesia, ultrasound guided Sham Quadratus Lumborum Block (QLB) will be performed with 30 mL saline.
Intervention Type
Procedure
Intervention Name(s)
posterior Quadratus Lumborum Block (QLB)
Intervention Description
Procedure (experimental): ultrasound guided posterior Quadratus Lumborum Block (QLB) Procedure (experimental): Sham Block
Primary Outcome Measure Information:
Title
Efficacy of the posterior quadratus lumborum block (QLB) versus placebo on morphine consumption during the first 24 hours after a total hip arthroplasty
Time Frame
the first 24 hours after a total hip arthroplasty

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe BIBOULET, MD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lapeyronie Teaching Hospital Montpellier
City
Montpellier
State/Province
Occitanie
ZIP/Postal Code
34934
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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