NCT04555291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 5, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

August 11, 2020

Last Update Submit

March 20, 2026

Conditions

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Opoïd consumption

    The main end point of this study is the decrease of opiod consumption in the 24h following THA.

    At 24 Hours

Secondary Outcomes (1)

  • morphine equivalent dose

    At 48 Hours

Study Arms (2)

Drug Ropivacaïne 2 mg/ml

EXPERIMENTAL

Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of ropivacaïne 2 mg/ml

Drug: Ropivacaine injection

NACL

PLACEBO COMPARATOR

Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of NACL

Other: NACL

Interventions

NACLOTHER

Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of NACL

NACL
Ropivacaine injectionDRUG

Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of ropivacaïne 2 mg/ml

Drug Ropivacaïne 2 mg/ml

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de nice - Anesthésie Réanimation

Nice, Alpes-Maritimes, 06001, France

Location

Institut Arnaut Tzanck

Nice, Alpes-Maritimes, 06700, France

Location

Related Publications (1)

  • Rozier R, Loiseleur A, Ciais C, Moulin O, Alais B, Marguerite K, Badia E, Tran L, Balbo J, Maurice-Szamburski A. Anterior quadratus lumborum block in total hip arthroplasty: a two-center, randomized, placebo-controlled trial showing no additional benefit over multimodal analgesia. Reg Anesth Pain Med. 2025 Feb 10:rapm-2024-106247. doi: 10.1136/rapm-2024-106247. Online ahead of print.

    PMID: 39929638RESULT

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Rozier Romain

    Anesthésie Réanimation - CHU de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2020

First Posted

September 18, 2020

Study Start

January 5, 2022

Primary Completion

October 6, 2023

Study Completion

October 10, 2024

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)