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

Not Applicable

Active, not recruiting

• Conditions: Total Hip Arthroplasty
• Interventions: Drug: Ropivacaine injection; Other: NACL

• Registration Number: NCT04555291
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-18
• Study Start: 2022-01-05
• Primary Completion: 2023-10-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Study Completion: 2024-10-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug Ropivacaïne 2 mg/ml	Ropivacaine injection	Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of ropivacaïne 2 mg/ml
NACL	NACL	Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of NACL

Primary Outcome Measures

Name	Time	Method
Opoïd consumption	At 24 Hours	The main end point of this study is the decrease of opiod consumption in the 24h following THA.

Secondary Outcome Measures

Name	Time	Method
morphine equivalent dose	At 48 Hours	following surgery at rest and in motion

Trial Locations

Locations (2)

Institut Arnaut Tzanck; 🇫🇷 Nice, Alpes-Maritimes, France

CHU de nice - Anesthésie Réanimation; 🇫🇷 Nice, Alpes-Maritimes, France