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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04555291

Collaborator

(none)

Enrollment

Locations

Arms

12.9

Anticipated Duration (Months)

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Arthroplasty	Drug: Ropivacaine injection Other: NACL	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

morphine equivalent dose [At 48 Hours]
following surgery at rest and in motion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de nice - Anesthésie Réanimation	Nice	Alpes-Maritimes	France	06001
2	Institut Arnaut Tzanck	Nice	Alpes-Maritimes	France	06700

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

Principal Investigator: Rozier Romain, Anesthésie Réanimation - CHU de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT04555291

Other Study ID Numbers:

19-PP-13

First Posted:

Sep 18, 2020

Last Update Posted:

Sep 14, 2021

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ropivacaine

Study Results

No Results Posted as of Sep 14, 2021