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

NCT03189290 | Completed

• 1 other identifier: 9798
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Total Hip Replacement

Outcome Measures

Primary Outcomes (1)

• Efficacy of the posterior quadratus lumborum block (QLB) versus placebo on morphine consumption during the first 24 hours after a total hip arthroplasty

  the first 24 hours after a total hip arthroplasty

Study Arms (2)

ropivacaine

ACTIVE COMPARATOR

Active Comparator: ropivacaine group \- Before general anaesthesia, ultrasound guided Quadratus Lumborum Block (QLB) will be performed with 30 mL 0.33% Ropivacaine

Procedure: posterior Quadratus Lumborum Block (QLB)

placebo

PLACEBO COMPARATOR

Sham Comparator: saline group \- Before general anaesthesia, ultrasound guided Sham Quadratus Lumborum Block (QLB) will be performed with 30 mL saline.

Procedure: posterior Quadratus Lumborum Block (QLB)

Interventions

posterior Quadratus Lumborum Block (QLB) PROCEDURE

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

placebo; ropivacaine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Lapeyronie Teaching Hospital Montpellier

Montpellier, Occitanie, 34934, France

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Philippe BIBOULET, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: June 16, 2017
• Study Start: July 6, 2017
• Primary Completion: September 10, 2018
• Study Completion: September 10, 2018
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

FR (1)