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

NCT04499716 | Completed

• 1 other identifier: 2020/04
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Total Knee Arthroplasty

Keywords

Knee arthroplasty, Regional anesthesia, Ropivacaine, Postoperative analgesia, Pain management, Opioids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Postoperative pain: Verbal Rating Scale (VRS)

  48 hours

• Oxynorm consumption in the first 24 hours post-surgery

  24 hours

• Ability to walk

  48 hours

• Quadricep mobilization

  48 hours

• Foot elevator muscle mobilization

  48 hours

Study Arms (2)

Arm 1: ITO group

ACTIVE COMPARATOR

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

Procedure: IPACK; Procedure: Femoral triangle block; Procedure: Obturator nerve block

Arm 2 : Quadri-block group

EXPERIMENTAL

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

Procedure: Obturator nerve block; Procedure: Femoral nerve block; Procedure: Sciatic nerve block; Procedure: Lateral femoral cutaneous nerve block

Interventions

IPACK PROCEDURE

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

Arm 1: ITO group

Femoral triangle block 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.

Arm 1: ITO group

Obturator nerve block 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 1: ITO group; Arm 2 : Quadri-block group

Femoral nerve block PROCEDURE

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

Arm 2 : Quadri-block group

Sciatic nerve block PROCEDURE

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

Arm 2 : Quadri-block group

Lateral femoral cutaneous nerve block PROCEDURE

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

Arm 2 : Quadri-block group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinique Medipole Garonne: lead

Study Sites (1)

Clinique Médipôle Garonne

Toulouse, Haute-Garonne, 31036, France

Location

Related Publications (1)

• 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.

  PMID: 35773028 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: December 8, 2020
• Primary Completion: May 7, 2021
• Study Completion: May 7, 2021
• Last Updated: June 7, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)