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

NCT ID: NCT07096375

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-20
• Study Completion Date: 2026-09-28

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.

Detailed Description

Postoperative Analgesia Management and Evaluation of Outcomes:

After the total knee arthroplasty ended, the patients will be transmitted to the post anaesthesia care unit (PACU). The same multimodal postoperative analgesia will be applied in the PACU in three groups, which will be consistent with ketorolac 50 mg every twelve hours and acetaminophen 1 g i.v. every eight hours will be both applied for 3 days. If the NRS score is higher than 4, 5 mg morphine will be administered as rescue analgesia. Eight mg of odanesteron will be given when severe nausea or vomiting occurs. Enoxaparin for four weeks postoperatively will be given as a thromboembolism prophylaxis. Finally, patients will be ambulated with the help of the walker after the first ten postoperative hours.

Assessment of outcomes:

Primary outcome:

Assessment of pain after completing the surgical procedure and wear off of spinal analgesia that will be confirmed by Bromage scale and cold sensation.

The total cumulative dose of used morphine to control pain from the postoperative in post anaesthesia care unit and in orthopaedic wards. Also, total opioid consumption will be recorded at 0-6, 6-12, and 12-24 h after surgery as primary outcome of the study.

Secondary outcome:

The secondary outcomes including assessment of pain by visual analogue scale (VAS) will be done postoperatively at 8 hours, 12 hours and 24 hours postoperatively.

Visual analogue scale (VAS) (scale 0-10, where 0 = no pain and 10 = worst imaginable pain). All the patients will have the VAS score explained and taught for self-assessment of pain at the time of enrolment for the study (Bringuier et al., 2009).

As well as the range of motion and quadriceps strength will be measured to grade the functional recovery of the knee joint after surgery after the first ten hours postoperatively. The protractor will be used for the range of motion. The interval of activities will be recorded three times a day, 6 h apart, and i will use the best value as the day's value. The quadriceps strength will be measured by asking the patient to flex the hip and knee and the complete knee extension. The outcome assessor will use resistance to knee extension and palpated the thigh muscles to measure muscle strength. No muscle movement will score 0 points, no joint movement with muscle contraction will score 1 point, no gravity resistance with joint movement will score 2 points, gravity resistance will score 3 points, partial counterforce resistance with gravity resistance will score 4 points, and normal joint function will score 5 points.

Also, blood samples for neutrophil-lymphocytic ratio (NLR) and platelet-lymphocytic ratio (PLR) will be collected at 12 and 24 h after surgery.

Conditions

Adductor Canal Block; Total Knee Replacement Surgery; Functional Recovery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Adductor canal block (ACB) + IPACK block

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.

Group Type: ACTIVE_COMPARATOR

Adductor Canal Block (ACB) + iPACK Block

Intervention Type: 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.

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

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.

Group Type: SHAM_COMPARATOR

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

Intervention Type: 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.

Interventions

Adductor Canal Block (ACB) + iPACK Block

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.

Intervention Type: PROCEDURE

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

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.

Intervention Type: PROCEDURE

Other Intervention Names

Adductor Canal Block (ACB); IPACK block; Adductor Canal Block; IPACK Block (sham injection)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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...)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Rana Magdy, Master

Role: CONTACT

Other Identifiers

MD187/2024

Identifier Type: -

Identifier Source: org_study_id