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

C

Centre Hospitalier Universitaire de Nice

Status

Active, not recruiting

Conditions

Total Hip Arthroplasty

Treatments

Other: NACL
Drug: Ropivacaine injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04555291
19-PP-13

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Drug Ropivacaïne 2 mg/ml
Experimental group
Description:
Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of ropivacaïne 2 mg/ml
Treatment:
Drug: Ropivacaine injection
NACL
Placebo Comparator group
Description:
Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of NACL
Treatment:
Other: NACL

Trial contacts and locations

2

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Central trial contact

Rozier Romain

Data sourced from clinicaltrials.gov

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