IPACK Block After Total Knee Arthroplasty

NCT ID: NCT04295421

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2022-07-31

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.

Detailed Description

This is a prospective, randomized and double blinded study

All patients received :

• Pregabalin 150 mg preoperatively 12 h before the surgery.
• Single-shot spinal anesthesia with 10 to 12 mg of bupivacaine 0.5% and 2.5ug sufentanil patients were randomly allocated to receive:
• Group 1: IPACK + ACB single shoot
• Group 2: contineous ACB For group 1: IPACK was realized after spinal anesthesia with 40 ml ropivacaine 0.2% All patients received ACB in the immediate postoperative period with 20 ml ropivacaine 0.2%

Post operative analgesia included:

• Paracetamol 1g IV every 6 hours
• Diclofenac sodium (50mg) 1 tablet x 2 per day
• Pregabalin 150 mg given orally once daily for a period of 4 weeks.
• PCA morphine (Patient Controlled Analgesia), as a rescue analgesia,
• Continuous ACB catheter for 48H with :

4 ml per hour 0.2% ropivacaine in group 2 4 ml per hour saline in group 1

Conditions

Knee Arthropathy; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Canal adductor block

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%.

Group Type: ACTIVE_COMPARATOR

adductor canal block

Intervention Type: 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%.

IPACK block

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

Group Type: EXPERIMENTAL

adductor canal block

Intervention Type: 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%.

IPACK block

Intervention Type: 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

Interventions

adductor canal block

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%.

Intervention Type: PROCEDURE

IPACK block

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• primary total knee arthroplasty under spinal anesthesia

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Kassab d'Orthopédie

OTHER

Sponsor Role: collaborator

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

Olfa kaabachi, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

khaireddine Raddaoui, MD

Role: PRINCIPAL_INVESTIGATOR

Tunis El Manar University

Locations

Institut Kassab D'Orthopedie

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

CE-IMKO 101/2019

Identifier Type: -

Identifier Source: org_study_id