IPACK Block After Total Knee Arthroplasty

Postoperative Pain Clinical Trial

Official title:

Comparison of Adductor Canal Block and IPACK Block With Adductor Canal Block Alone After Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04295421
• Other study ID #: CE-IMKO 101/2019
• Status: Completed
• Phase: N/A
• Start date: March 31, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2024
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 31, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• 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%.
• 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

Locations

Country	Name	City	State
Tunisia	Institut Kassab D'Orthopedie	Tunis

Sponsors (2)

Lead Sponsor	Collaborator
University Tunis El Manar	Institut Kassab d'Orthopédie

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	total Morphine consumption	Day 2
Secondary	Pain score at rest	numerical rating scale [0=no pain ; 10=worste pain]	Day 2
Secondary	Pain score during mouvment	numerical rating scale	Day 2 [0=no pain ; 10=worste pain]
Secondary	Ambulation distance	number of steps walked by the patient	Day 2
Secondary	Chronic pain	DN4 score [0=minimum to 10= worste score]	Month 6
Secondary	functional status	KOOS PS score [0=minimum to 28= worste score]	Month 6