Quadriblock Versus "IPACK + Femoral Triangle Block + Obturator Nerve Block" in Total Knee Arthroplasty

NCT ID: NCT04499716

Last Updated: 2021-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-08

Study Completion Date

2021-05-07

Brief Summary

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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

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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.

Conditions

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Primary Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Arm 1: ITO group

Arm 1: IPACK combined with femoral triangle and obturator nerve blocks

Group Type ACTIVE_COMPARATOR

IPACK

Intervention Type PROCEDURE

25 milliliters of ropivacaine 0.3% will be injected between popliteal artery and femur.

Femoral triangle block

Intervention Type PROCEDURE

25 milliliters of ropivacaine 0.3% will be injected on the lateral side of the femoral artery at the distal part of the femoral triangle.

Obturator nerve block

Intervention Type PROCEDURE

20 milliliters of ropivacaine 0.3% will be injected between the adductor magnus and adductor brevis muscles and between the adductor brevis muscle the pectineus.

Arm 2 : Quadri-block group

Arm 2 : Femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks

Group Type EXPERIMENTAL

Obturator nerve block

Intervention Type PROCEDURE

20 milliliters of ropivacaine 0.3% will be injected between the adductor magnus and adductor brevis muscles and between the adductor brevis muscle the pectineus.

Femoral nerve block

Intervention Type PROCEDURE

20 milliliters of ropivacaine 0.3% will be injected in supine position under the fascia iliaca lateral to the femoral artery.

Sciatic nerve block

Intervention Type PROCEDURE

25 milliliters of ropivacaine 0.3% will be injected in prone position in the subgluteal space by lateral approach.

Lateral femoral cutaneous nerve block

Intervention Type PROCEDURE

5 milliliters of ropivacaine 0.3% will be injected laterally to the sartorius muscle.

Interventions

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IPACK

25 milliliters of ropivacaine 0.3% will be injected between popliteal artery and femur.

Intervention Type PROCEDURE

Femoral triangle block

25 milliliters of ropivacaine 0.3% will be injected on the lateral side of the femoral artery at the distal part of the femoral triangle.

Intervention Type PROCEDURE

Obturator nerve block

20 milliliters of ropivacaine 0.3% will be injected between the adductor magnus and adductor brevis muscles and between the adductor brevis muscle the pectineus.

Intervention Type PROCEDURE

Femoral nerve block

20 milliliters of ropivacaine 0.3% will be injected in supine position under the fascia iliaca lateral to the femoral artery.

Intervention Type PROCEDURE

Sciatic nerve block

25 milliliters of ropivacaine 0.3% will be injected in prone position in the subgluteal space by lateral approach.

Intervention Type PROCEDURE

Lateral femoral cutaneous nerve block

5 milliliters of ropivacaine 0.3% will be injected laterally to the sartorius muscle.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Medipole Garonne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Médipôle Garonne

Toulouse, Haute-Garonne, France

Site Status

Countries

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France

References

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Marty P, Chassery C, Rontes O, Vuillaume C, Basset B, Merouani M, Marquis C, De Lussy A, Ferre F, Naudin C, Joshi GP, Delbos A. Combined proximal or distal nerve blocks for postoperative analgesia after total knee arthroplasty: a randomised controlled trial. Br J Anaesth. 2022 Sep;129(3):427-434. doi: 10.1016/j.bja.2022.05.024. Epub 2022 Jun 28.

Reference Type DERIVED
PMID: 35773028 (View on PubMed)

Other Identifiers

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2020/04

Identifier Type: -

Identifier Source: org_study_id

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