Comparative Study Between Ultrasound-Guided IPACK Block (Interspace Between the Popliteal Artery and the Posterior Capsule of the Knee) with Adductor Canal Block Versus Adductor Canal Block Alone for Postoperative Pain Management in Total Knee Arthroplasty

NCT06783712 | Recruiting Phase 1 DMC

• 1 other identifier: FMASU MS47/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will compare the effectiveness of the interspace between the popliteal artery and posterior capsule of the knee (IPACK) block with adductor canal block versus adductor canal block alone for postoperative analgesia in total knee arthroplasty with consequently improved early ambulation and functional rehabilitation.

Conditions

The Time Interval Between Injection of the Block and the First Rescue Analgesia Dose Given. Postoperative Pain Assessment Using NRS Score for Pain

Outcome Measures

Primary Outcomes (1)

• The time interval between injection of the block and the first rescue analgesia dose given

  24 hours from block injection

Study Arms (2)

Group I: Adductor canal block alone

ACTIVE COMPARATOR

Procedure: Adductor canal block

Group II: IPACK block with Adductor canal block

ACTIVE COMPARATOR

Procedure: Adductor Canal Block (ACB) + iPACK Block

Interventions

Adductor canal block PROCEDURE

Group I: Patients will receive the ultrasound-guided Adductor canal block (ACB) by the supervisors of the research performed just after skin closure. ACB will be performed under complete aseptic conditions. Using a high frequency (6-15MHz) linear probe of an ultrasound machine (Sonosite turbo M, Bothell, Washington, USA) covered with a sterile sheath and 100 mm needle SonoPlex (B-Braun Medical Inc., Bethlehem, PA, USA). ACB block will be performed while the patient is in a supine position at the point midway between the anterior superior iliac spine and the upper pole of the patella. The adductor canal will be located as a hyperechoic structure beneath the sartorius muscle, 100 mm needle SonoPlex will be advanced with the guidance of ultrasound in an in-plane technique and 20 ml bupivacaine (Marcaine) 0.25% will be injected.

Group I: Adductor canal block alone

Adductor Canal Block (ACB) + iPACK Block PROCEDURE

Group II: The patients will receive ACB by the supervisors of the research just after skin closure as previously described in group I and then an IPACK block will be performed. IPACK block will be performed under complete aseptic precautions using the ultrasound machine with the high-frequency linear probe covered with a sterile sheath and 100 mm needle SonoPlex. IPACK block will be performed while the patient is in a supine position with slight knee flexion, the probe will be applied to the popliteal fossa for identification of the popliteal artery and femur. Then the probe will be distally slided for revealing the two femoral condyles followed by proximal sliding of the probe until the humps of the femoral condyles disappear and the flat metaphysis appear. A needle will be advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reaches the medial edge of the femur,20 ml bupivacaine 0.25% will be injected incrementally

Group II: IPACK block with Adductor canal block

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• The patient refusal to give written consent.
• Previously known allergy to one of the drugs being used in the study.
• Physical status: ASA grades more than III
• History or evidence of coagulopathy, use of anti-coagulant or anti-platelet therapy.
• Patients with neuromuscular disorders
• Injection site infection.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt, 11111, Egypt

RECRUITING

Study Officials

• Hager Talal Mohamed, MBBCH

  Anesthesia Resident Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hager Talal Mohamed, MBBCH

CONTACT

+201119050190; hager.talal5@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: January 9, 2025
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)