Comparison of Combination of Proximal ACB and iPACK With Large-Volume Distal ACB for Early Mobilization After TKR

NCT06525493 | Completed

• 1 other identifier: 585/UN2.F1/ETIK/PPM.00.02/2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Large-volume distal ACB is not superior to combination of proximal ACB and iPACK in facilitating early mobilization after TKR. Block performing time of distal ACB was significantly shorter compared to the combination of proximal ACB and iPACK

Conditions

Adductor Canal Block; Postoperative Pain; Regional Anesthesia

Keywords

Total Knee Replacement; Adductor Canal Block; Postoperative Pain; Regional Anesthesia; Postoperative Mobilization; TUG Test

Outcome Measures

Primary Outcomes (3)

• Timed Up and Go test on Postoperative Day 1 (POD 1)

  The Timed Up and Go (TUG) test is a functional mobility assessment used to evaluate a person's ability to stand up from a chair, walk a short distance, turn around, return to the chair, and sit down again. It assesses balance, gait, and functional mobility, which are crucial aspects of postoperative recovery.

  The test is conducted specifically on the first day after the surgery, known as Postoperative Day 1 (POD 1)

• Numeric Rating Scale

  The NRS is a commonly used tool to assess pain intensity. Patients are typically asked to rate their pain on a numerical scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain

  The NRS assessments are conducted at 6 hours, 12 hours, and 24 hours after the surgery

• Total 24 hours morphine consumption

  This measures the total amount of morphine consumed by patients within the first 24 hours after surgery. It reflects the effectiveness of pain management strategies and the need for opioid analgesia

  The measurement is taken over the entire 24-hour period following the surgery

Study Arms (2)

Group A

EXPERIMENTAL

Patients receive the large-volume distal adductor canal block (ACB). In this technique, a linear transducer is placed on the medial aspect, approximately one fourth of the distal thigh to identify the Adductor Hiatus, and the injection is performed in-plane near that point using ropivacaine.

Procedure: Regional Anesthesia

Group B

EXPERIMENTAL

This arm involves a combination of two regional anesthesia techniques: proximal adductor canal block (ACB) and iPACK. In proximal ACB, the transducer is placed in the middle of the thigh, and the injection is performed in-plane approximately 1-2 cm distal from a specific point. Meanwhile, in iPACK, the curvilinear transducer is positioned on the posteromedial aspect of the distal thigh, and the injection is performed between the popliteal artery and the femur

Procedure: Regional Anesthesia

Interventions

Regional Anesthesia PROCEDURE

The interventions are three different regional anesthesia techniques: Proximal Adductor Canal Block (ACB), iPACK (Interspace between the Popliteal Artery and the Capsule of the Posterior Knee), and Large-Volume Distal Adductor Canal Block (Large ACB distal). all three interventions were administered using ropivacaine 0.2%. However, there were differences in the volumes injected for each regional anesthesia technique. Proximal ACB: 15 mL of ropivacaine 0.2%. iPACK: 20 mL of ropivacaine 0.2%. Large ACB distal: 35 mL of ropivacaine 0.2%

Group A; Group B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 50 - 80 years who underwent total knee replacement surgery

You may not qualify if:

• Systemic allergy, anaphylactic reaction, and occurrence of cardiac arrest
• Intraoperative fracture
• Change to general anesthesia
• Patient who decides to withdraw from the study.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital, Jakarta Pusat, DKI Jakarta, Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

ID (1)