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NCT04555291 Clinical Trial

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

Total Hip Arthroplasty Clinical Trial

— QLB-3  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04555291
Other study ID # 19-PP-13
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 5, 2022
Est. completion date October 6, 2024

Study information
Verified date March 2024
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date October 6, 2024
Est. primary completion date October 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Ropivacaine injection
Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of ropivacaïne 2 mg/ml
Other:
• NACL
Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of NACL

Locations
Country Name City State
France CHU de nice - Anesthésie Réanimation Nice Alpes-Maritimes
France Institut Arnaut Tzanck Nice Alpes-Maritimes

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Opoïd consumption The main end point of this study is the decrease of opiod consumption in the 24h following THA. At 24 Hours
Secondary morphine equivalent dose following surgery at rest and in motion At 48 Hours
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