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

Not Applicable

Completed

• Conditions: Primary Total Knee Arthroplasty
• Interventions: Procedure: IPACK; Procedure: Femoral triangle block; Procedure: Femoral nerve block; Procedure: Obturator nerve block; Procedure: Sciatic nerve block; Procedure: Lateral femoral cutaneous nerve block

• Registration Number: NCT04499716
• Lead Sponsor: Clinique Medipole Garonne

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.

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-05
• Study Start: 2020-12-08
• Primary Completion: 2021-05-07
• Study Completion: 2021-05-07
• Last Update Submitted: 2021-06-04
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: ITO group	Obturator nerve block	Arm 1: IPACK combined with femoral triangle and obturator nerve blocks
Arm 2 : Quadri-block group	Obturator nerve block	Arm 2 : Femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks
Arm 2 : Quadri-block group	Lateral femoral cutaneous nerve block	Arm 2 : Femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks
Arm 1: ITO group	Femoral triangle block	Arm 1: IPACK combined with femoral triangle and obturator nerve blocks
Arm 1: ITO group	IPACK	Arm 1: IPACK combined with femoral triangle and obturator nerve blocks
Arm 2 : Quadri-block group	Femoral nerve block	Arm 2 : Femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks
Arm 2 : Quadri-block group	Sciatic nerve block	Arm 2 : Femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks

Primary Outcome Measures

Name	Time	Method
Postoperative analgesia, defined by the morphine consumption in the first 48 hours post-surgery.	48 hours	Total amount of oxynorm (mg) administered during the first 48 hours post-surgery.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain: Verbal Rating Scale (VRS)	48 hours	Pain will be assessed every 6 hours using a Verbal Rating Scale (VRS) ranging from 0 to 10 (0=no pain, 10=worst possible pain).
Oxynorm consumption in the first 24 hours post-surgery	24 hours	Total amount of oxynorm (mg) administered during the first 24 hours post-surgery.
Ability to walk	48 hours	0: unable to get up; 1: able to get up but not to walk; 2: walk \<50 m; 3: walk \> 50 m
Foot elevator muscle mobilization	48 hours	0: paralysis; 1: paresis; 2: normal contraction
Side effects of opioids	48 hours	Collect side effects associated with oxynorm : nausea or vomiting, drowsiness, constipation, urinary retention, itching, disorientation.
Quadricep mobilization	48 hours	0: paralysis; 1: paresis, 2: normal contraction

Trial Locations

Locations (1)

Clinique Médipôle Garonne; 🇫🇷 Toulouse, Haute-Garonne, France