Study of the QUadratus Lumborum Bloc in Total Hip ARthroplasty: Efficacy and Safety

NCT ID: NCT03189290

Last Updated: 2019-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-06
• Study Completion Date: 2018-09-10

Brief Summary

The purpose of this prospective research study is to determine the best way to manage post-operative pain after a total hip arthroplasty. Currently, there is no standard of care for managing post-operative pain in these patients. The quadratus lumborum block (QLB) first described by Blanco in 2007, is a promising technique in this indication: recently, there is a growing evidence for the use of the QLB as an alternative technique for pain management after hip surgery.

Detailed Description

A sample size of 100 patients (50 per group) was calculated based on 20% reduction in morphine consumption with 0.05% significance and a power of 0.8.

After ethical committee approval, eligible patients scheduled to have a fast-track total hip arthroplasty are screened during preoperative evaluation clinic. Informed written consent will be obtained from all patients during pre-anesthesia visit the day before surgery (J-1). Consenting patients will be randomized the day of surgery (J0) to undergo QLB with ropivacaine ("ropivacaine group") or normal saline ("saline group").

Before general anesthesia, all patients will have a needle-insertion posterior to the quadratus lumborum muscle avec injection of either ropivacaine in the "ropivacaine group" or normal saline in the "saline group".

After general anesthesia induction, dexamethasone and ketamine will be given to all patients.

Conditions

Postoperative Pain; Total Hip Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ropivacaine

Active Comparator: ropivacaine group

• Before general anaesthesia, ultrasound guided Quadratus Lumborum Block (QLB) will be performed with 30 mL 0.33% Ropivacaine

Group Type: ACTIVE_COMPARATOR

posterior Quadratus Lumborum Block (QLB)

Intervention Type: PROCEDURE

Procedure (experimental): ultrasound guided posterior Quadratus Lumborum Block (QLB) Procedure (experimental): Sham Block

placebo

Sham Comparator: saline group

• Before general anaesthesia, ultrasound guided Sham Quadratus Lumborum Block (QLB) will be performed with 30 mL saline.

Group Type: PLACEBO_COMPARATOR

posterior Quadratus Lumborum Block (QLB)

Intervention Type: PROCEDURE

Procedure (experimental): ultrasound guided posterior Quadratus Lumborum Block (QLB) Procedure (experimental): Sham Block

Interventions

posterior Quadratus Lumborum Block (QLB)

Procedure (experimental): ultrasound guided posterior Quadratus Lumborum Block (QLB) Procedure (experimental): Sham Block

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists Physical Classification Status (ASA) I to III
• Age ≥ 18 years
• Scheduled for fast-track total hip arthroplasty
• Written informed consent

Exclusion Criteria

• Protected patients or patients incapable of giving written informed consent
• Pregnant or breastfeeding woman
• Vulnerable adult
• Contraindication for fast-track surgery
• Inability to comprehend or participate in pain scoring scales
• Allergy to study drugs
• Severe coagulopathy
• Chronic kidney disease with glomerular filtration rate (GFR) ≤ 30 mL/min (estimated by the Cockcroft & Gault formula)
• Chronic pain (treated by nonsteroidal anti-inflammatory drugs, opioids, neuroleptic drugs, antidepressant or anticonvulsants)
• Peripheral neuropathy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe BIBOULET, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Lapeyronie Teaching Hospital Montpellier

Montpellier, Occitanie, France

Countries

France

Other Identifiers

9798

Identifier Type: -

Identifier Source: org_study_id