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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Total Knee Arthroplasty
• Intervention / Treatment: Procedure: IPACK; Procedure: Femoral triangle block; Procedure: Obturator nerve block; Procedure: Femoral nerve block; Procedure: Sciatic nerve block; Procedure: Lateral femoral cutaneous nerve block

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31036
      • Clinique Médipole Garonne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: ITO group; Arm 1: IPACK combined with femoral triangle and obturator nerve blocks	Procedure: IPACK; 25 milliliters of ropivacaine 0.3% will be injected between popliteal artery and femur.; 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.; 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.
Experimental: Arm 2 : Quadri-block group; Arm 2 : Femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks	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.; 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.; Procedure: Sciatic nerve block; 25 milliliters of ropivacaine 0.3% will be injected in prone position in the subgluteal space by lateral approach.; Procedure: Lateral femoral cutaneous nerve block; 5 milliliters of ropivacaine 0.3% will be injected laterally to the sartorius muscle.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain: Verbal Rating Scale (VRS)	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).	48 hours
Oxynorm consumption in the first 24 hours post-surgery	Total amount of oxynorm (mg) administered during the first 24 hours post-surgery.	24 hours
Ability to walk	0: unable to get up; 1: able to get up but not to walk; 2: walk <50 m; 3: walk > 50 m	48 hours
Quadricep mobilization	0: paralysis; 1: paresis, 2: normal contraction	48 hours
Foot elevator muscle mobilization	0: paralysis; 1: paresis; 2: normal contraction	48 hours
Side effects of opioids	Collect side effects associated with oxynorm : nausea or vomiting, drowsiness, constipation, urinary retention, itching, disorientation.	48 hours

Collaborators and Investigators

• Sponsor: Clinique Medipole Garonne

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Actual): May 7, 2021
• Study Completion (Actual): May 7, 2021

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 7, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Knee arthroplasty, Regional anesthesia, Ropivacaine, Postoperative analgesia, Pain management, Opioids
• Other Study ID Numbers: 2020/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No