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Completed

NCT Number: NCT03189290

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lapeyronie Teaching Hospital Montpellier

Montpellier, Occitanie, 34934, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Patient covered by health insurance 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

Treatment and study plan

posterior Quadratus Lumborum Block (QLB)

Procedure

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

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

    Time frame: the first 24 hours after a total hip arthroplasty

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: SQUARE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 16, 2017
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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