IPACK Block After Total Knee Arthroplasty

NCT04295421 | Completed

• 1 other identifier: CE-IMKO 101/2019
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Adductor canal block (ACB) is a peripheral nerve blockade technique that provides good pain control in patients undergoing total knee arthroplasty (TKA) which however does not relieve posterior knee pain. The recent technique of an ultrasound-guided local anesthetic infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) has shown promising results in providing significant posterior knee analgesia without affecting the motor nerves. The hypothesis was that the combination of ACB + IPACK will provide better pain relief and improve knee function in the immediate postoperative period compared to ACB alone.

Conditions

Knee Arthropathy; Postoperative Pain

Keywords

knee arthoplasty; nerve block; analgesia

Outcome Measures

Primary Outcomes (1)

• Morphine consumption

  total Morphine consumption

  Day 2

Secondary Outcomes (5)

• Pain score at rest

  Day 2

• Pain score during mouvment

  Day 2 [0=no pain ; 10=worste pain]

• Ambulation distance

  Day 2

• Chronic pain

  Month 6

• functional status

  Month 6

Study Arms (2)

Canal adductor block

ACTIVE COMPARATOR

ACB was done in the immediate postoperative period under a high-frequency ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.2% ropivacaine was injected in the canal using a 22-gauge 100-mm short-beveled regional block needle and a catheter was kept for 48H with 4 ml/h ropivacaine 0.2%.

Procedure: adductor canal block

IPACK block

EXPERIMENTAL

IPACK was realized after spinal anesthesia. Patient was placed in a supine position and knee placed in position of 90° flexion. A low-frequency ultrasound probe was positioned in the popliteal crease, and the needle was inserted from medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle was placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.2% ropivacaine was injected for each side. A ACB was done postoperatively with 20 ml ropivacaine 0.2% and a catheter was kept for 48H with 4 ml/h saline

Procedure: adductor canal block; Procedure: IPACK block

Interventions

adductor canal block PROCEDURE

ACB was done in the immediate postoperative period under a high-frequency ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.2% ropivacaine was injected in the canal using a 22-gauge 100-mm short-beveled regional block needle and a catheter was kept for 48H with 4 ml/h ropivacaine 0.2%.

Canal adductor block; IPACK block

IPACK block PROCEDURE

IPACK block was realized after spinal anesthesia with 40 ml 0.2% ropivacaine and at the end of surgery , patients were given ACB with 20 ml 0.2% ropivacaine and continued with 4 ml/H saline for 48H

IPACK block

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• primary total knee arthroplasty under spinal anesthesia

You may not qualify if:

• Contraindication or refusal to regional anesthesia
• Contraindication to non steroidal anti inflammatory (NSAID's)
• Allergy to opioids
• Allergy to paracetamol
• Creatinine clearance \< 30ml/min
• Weight\<50 kg or \>100kg

Sponsors & Collaborators

• University Tunis El Manar: lead
• Institut Kassab d'Orthopédie: collaborator

Study Sites (1)

Institut Kassab D'Orthopedie

Tunis, 2010, Tunisia

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• khaireddine Raddaoui, MD

  Tunis El Manar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 4, 2020
• Study Start: March 31, 2020
• Primary Completion: March 30, 2022
• Study Completion: July 31, 2022
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

TU (1)