Analgesic Effect of the QLB-3 for Patients Undergoing a Total Hip Surgery (QLB-3)

Analgesic Efficiency of the Type 3 Quadratum Lumborum Block in Patients Undergoing Total Hip Arthroplasty : a Randomized Double Blinded Trial

Total hip arthroplasty (THA) is one of the main elective orthopedic surgery. Recent studies have proven that patients undergoing an elective THA who are part of a fast track surgery program including an opioid free anesthesia (OFA) presented a decrease of mortality and a reduced in-hospital length of stay. Based on the anatomical knowledges, the Quadratus Lumborum Block seems to be an interesting locoregional technique for patients undergoing THA. So far, there is no recommanded locoregional aesthesia in this indication. The investigators hypothezised that QLB would give an efficient analgesia in the 24h following a THA.

Therefor, the study performed a prospective, randomized, double blind trial in the Nice Universitary hospital of Pasteur 2 and in Arnault Tzanck Institute among all patients who underwent THA, comparing a QLB using ropivacaïne 2mg/ml 20ml vs isotonic saline solution 20 ml.The main end-point is the decrease opiod consumption in the 24h following THA.

Study Overview

• Status: Active, not recruiting
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Drug: Ropivacaine injection; Other: NACL

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rozier Romain; Phone Number: +33492038580; Email: rozier.r@chu-nice.fr

Study Locations

• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06001
      • CHU de nice - Anesthésie Réanimation
    • Nice, Alpes-Maritimes, France, 06700
      • Institut Arnaut Tzanck

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• All adult patients with unilateral programmed total hip prosthesis surgery are included in the absence of inclusion criteria.

• Obligation for all patients to be affiliated with social security
• Patient Informed Consent Signature

Exclusion Criteria:

• chronic opiod consumption
• pregnancy
• mental disorder that prevents the usage of the numeric analog scale

• Contra indications of the realization of QLB

  • Local infection
  • Allergic to the local anesthesia
  • Hemostasis disorder
  • Incapacity of giving the consent : individuals under guardianship by court order, or under judicial protection

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug Ropivacaïne 2 mg/ml; Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of ropivacaïne 2 mg/ml	Drug: Ropivacaine injection; Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of ropivacaïne 2 mg/ml
Placebo Comparator: NACL; Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of NACL	Other: NACL; Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of NACL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opoïd consumption	The main end point of this study is the decrease of opiod consumption in the 24h following THA.	At 24 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morphine equivalent dose	following surgery at rest and in motion	At 48 Hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Rozier Romain, Anesthésie Réanimation - CHU de Nice

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): October 6, 2023
• Study Completion (Estimated): October 6, 2024

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 19-PP-13

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