Coupling of IPACK Block With Adductor Canal Block Versus Adductor Canal Block Alone on Pain, Functional Recovery and Inflammatory Response After Knee Replacement

NCT07096375 | Not Yet Recruiting DMC

• 1 other identifier: MD187/2024
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to compare the Competency of coupling of IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Postoperative Pain after total knee replacement as well as Functional Recovery and Inflammatory Response and range of motion postoperatively.

Conditions

Adductor Canal Block; Total Knee Replacement Surgery; Functional Recovery

Keywords

IPACK block; Adductor Canal Block; Inflammatory Response

Outcome Measures

Primary Outcomes (1)

• The aim of this study is to compare the Competency of coupling of IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Postoperative Pain after total knee replacement.

  Total cumulative dose of used morphine (mg) to control pain will be recorded at 0 hour -6 hours, 6 hours -12 hours and 12 hours - 24 hours after surgery from postoperative in post anaesthesia care unit and in orthopaedic wards as primary outcome of the study.

  At 0 hour -6 hours, 6 hours-12 hours and 12 hours - 24 hours after surgery

Secondary Outcomes (3)

• The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively

  Postoperative Pain scores at rest and during active flexion 45◦ will be recorded at 8 hours, 12 hours and 24 hours postoperative.

• The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively

  Range of motion and quadriceps strength will be measured after first 10 hours, three times a day with 6 hours apart.

• The aim of this study is to compare IPACK Block with Adductor Canal Block versus Adductor Canal Block Alone on Functional Recovery and Inflammatory Response and range of motion postoperatively.

  Neutrophil-lymphocytic ratio and Platelet-lymphocytic ratio will be collected at 12 hours and 24 hours postoperative.

Study Arms (2)

Adductor canal block (ACB) + IPACK block

ACTIVE COMPARATOR

Group A: 25 patients will receive adductor canal block under ultrasound using 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound using 15 ml bupivacaine 0.25% at the start of surgery. IPACK Block which the patient will be placed in a supine position and knee will be placed in position of 90° flexion. A low-frequency ultrasound probe will be positioned in the popliteal crease, and a spinal needle will be inserted from the 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 will be placed 1-2 cm beyond the lateral edge of the artery, and 15 ml of bupivacaine 0.25% will be injected after negative aspiration.

Procedure: Adductor Canal Block (ACB) + iPACK Block

Adductor Canal Block (ACB) + IPACK (sham injection)

SHAM COMPARATOR

Group B : 25 patients will receive Adductor canal block only under ultrasound guide using 20ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound using 15 ml of saline (sham injection) at the start of the surgery. The patients in Group B will receive ACB and IPACK block (sham injection) as described above.

Procedure: Adductor Canal Block (ACB) + iPACK Block (sham injection)

Interventions

Adductor Canal Block (ACB) + iPACK Block PROCEDURE

Adductor Canal Block (ACB) in the immediate preoperative period under a high-frequency ultrasound guidance in which the adductor canal is identified beneath the sartorius muscle and 20 ml of bupivacaine 0.25% will be injected in the canal using a 22-gaugusing a 22-gauge 100-mm short-bevelled regional block needle. IPACK Block which the patient will be placed in a supine position and knee will be placed in position of 90° flexion. A low-frequency ultrasound probe will be positioned in the popliteal crease, and a spinal needle will be inserted from the 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 will be placed 1-2 cm beyond the lateral edge of the artery, and 15 ml of bupivacaine 0.25% will be injected after negative aspiration.

Also known as: Adductor Canal Block (ACB), IPACK block

Adductor canal block (ACB) + IPACK block

Adductor Canal Block (ACB) + iPACK Block (sham injection) PROCEDURE

All patients will receive Adductor Canal Block in the immediate preoperative period under a high-frequency ultrasound guidance in which the adductor canal is identified beneath the sartorius muscle and 20 ml of bupivacaine 0.25% will be injected in the canal using a 22-gauge 100-mm short-bevelled regional block needle IPACK block which the patient will be placed in a supine position and knee will be placed in position of 90° flexion. A low-frequency ultrasound probe will be positioned in the popliteal crease, and a spinal needle will be inserted from the 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 will be placed 1-2 cm beyond the lateral edge of the artery, and 15 ml of normal saline will be injected after negative aspiration.

Also known as: Adductor Canal Block, IPACK Block (sham injection)

Adductor Canal Block (ACB) + IPACK (sham injection)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing total knee replacement.
• ASA physical status I to III
• Sex (males and females).
• Age 20 - 70 years.

You may not qualify if:

• Patients undergoing bilateral or revision total knee replacement.
• ASA physical status more than III
• Age less than 20 or older than 70
• severe renal insufficiency ( Estimated Glomerular filtration rate eGFR \< 15 mL/min/1.73 m2 ).
• history of arrhythmia or seizures.
• Hypersensitivity to local anesthetics.
• Preexisting peripheral neuropathy and prior vascular surgery on femoral vessels on operated site.
• Infection near site of injection e.g. osteomyelitis, septic knee joint, etc.
• Patient refusal or with difficulties in comprehending numeric pain rating scale (NRS) pain scores
• Any contraindications for spinal anesthesia. (eg.: refusal of patients, coagulopathy, use of anticoagulants or antiplatelets...)

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

salicylhydroxamic acid

Central Study Contacts

Rana Magdy, Master

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: July 31, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): June 28, 2026
• Study Completion (Estimated): September 28, 2026
• Last Updated: July 31, 2025

Record last verified: 2024-11