IPACK Block After Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Knee Arthropathy; Postoperative Pain

• Registration Number: NCT04295421
• Lead Sponsor: University Tunis El Manar

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

Study Timeline

• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-04
• Study Start: 2020-03-31
• Primary Completion: 2022-03-30
• Study Completion: 2022-07-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-11
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Morphine consumption	Day 2	total Morphine consumption

Secondary Outcome Measures

Name	Time	Method
Pain score during mouvment	Day 2 [0=no pain ; 10=worste pain]	numerical rating scale
Pain score at rest	Day 2	numerical rating scale \[0=no pain ; 10=worste pain\]
Chronic pain	Month 6	DN4 score \[0=minimum to 10= worste score\]
Ambulation distance	Day 2	number of steps walked by the patient
functional status	Month 6	KOOS PS score \[0=minimum to 28= worste score\]

Trial Locations

Locations (1)

Institut Kassab D'Orthopedie; 🇹🇳 Tunis, Tunisia