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Clinical Trials/NCT04499716
NCT04499716
Completed
Not Applicable

Quadriblock Versus "IPACK + Femoral Triangle Block + Obturator Nerve Block" in Total Knee Arthroplasty: a Randomized Controlled Clinical Trial

Clinique Medipole Garonne1 site in 1 country90 target enrollmentDecember 8, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Total Knee Arthroplasty
Sponsor
Clinique Medipole Garonne
Enrollment
90
Locations
1
Primary Endpoint
Postoperative analgesia, defined by the morphine consumption in the first 48 hours post-surgery.
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery.

Postoperative pain management requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). For optimal pain management, several peripheral nerve blocks should be associated. Thus, a recent study shows that the combination of IPACK, femoral triangle and obturator nerve blocks (ITO blocks) provides an effective pain control after TKA.

The hypothesis of this study is that a quadruple nerve block combining femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks (quadri-block) could improve analgesia after TKA.

The main objective of this monocenter, prospective, randomized, open-label, controlled trial is to assess the effect of quadri-block on morphine consumption after TKA compared to ITO blocks.

Detailed Description

In the pre-anaesthesia room, after the implementation of classical monitoring with an oxygen mask and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to SFAR (French Society of Anesthesia \& Intensive Care Medecine) recommendations and injection of 10 mg of IV dexamethasone. The patients will be then randomized in 2 groups: * ITO group (usual technique): IPACK combined to femoral triangle and obturator nerve blocks * Quadriblock group (experimental technique): femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks. An experienced anesthetist will perform ultrasound-guided blocks 30 minutes before surgery with ropivacaine 0.3%, total volume of 70 ml. In the operating room, general anesthesia will be induced by intravenous ketamine (0.4 mg/kg) and propofol (3 mg/kg). Anesthesia will be maintained with propofol. Postoperative analgesia protocol : * Multimodal analgesia will be instituted from the end of the surgery by the administration of paracetamol (1 g) and ketoprofen (100 mg). * In post-anesthesia care unit (PACU): oxynorm titration if VRS (pain score) \>3 according to the centre's usual care. * In ward: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day); oxynorm (10 mg, lockout interval: 4 h) if VRS (pain score) \>3.

Registry
clinicaltrials.gov
Start Date
December 8, 2020
End Date
May 7, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years and older,
  • Primary total knee arthroplasty
  • Consent for participation,
  • Affiliation to a social security system

Exclusion Criteria

  • Preoperative morphine use
  • Chronic pain syndrome
  • Contraindication to any drugs used in the protocol (paracetamol, ketoprofen, oxynorm, propofol, ketamine, ropivacaine)
  • Valgus \> 9°
  • Pregnant or breastfeeding women
  • Patients under protection of the adults (guardianship, curators or safeguard of justice)

Outcomes

Primary Outcomes

Postoperative analgesia, defined by the morphine consumption in the first 48 hours post-surgery.

Time Frame: 48 hours

Total amount of oxynorm (mg) administered during the first 48 hours post-surgery.

Secondary Outcomes

  • Postoperative pain: Verbal Rating Scale (VRS)(48 hours)
  • Oxynorm consumption in the first 24 hours post-surgery(24 hours)
  • Ability to walk(48 hours)
  • Foot elevator muscle mobilization(48 hours)
  • Side effects of opioids(48 hours)
  • Quadricep mobilization(48 hours)

Study Sites (1)

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