Peri-articular Injection and (IPACK) With Adductor Canal Block in Total Knee Arthroplasty.

NCT04396652 | Completed

• 2 other identifiers: 33748/3/20Tanta University
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized double blind controlled study to evaluate the post-operative analgesic effect of adductor canal block (ACB) or peri-articular injection (PAIs) compared to combined adductor canal block and infiltration of the interspace between popliteal artery and the capsule of posterior knee block ( IPACK) in patient undergoing total knee arthroplasty

Conditions

Postoperative Pain; Regional Anesthesia

Keywords

peri-articular injection; adductor canal block; IPACK; Total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Post-operative pain

  Post-operative pain will be assessed at rest and during physiotherapy by Numeric Rating Scale from (0-10) '0' representing "no pain" to '10' representing "worst pain imaginable"

  After the resolution of the effect of spinal anesthesia for 72 hours postoperative

Secondary Outcomes (3)

• Postoperative analgesia

  First 24 hours postoperatively

• Duration of the block

  First 24 hours postoperatively

• Effect on Motor function

  Each day till the third postoperative day

Study Arms (3)

Adductor canal block (ACB) group

EXPERIMENTAL

Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal

Procedure: Adductor canal block (ACB) group

Peri-articular injection group

EXPERIMENTAL

Patients in group II will receive intraoperative peri-articular (cocktail) injection and will be performed by a single surgeon. A periarticular cocktail injection consisting of 90 mL of normal saline, 17.5 mL of 0.5% levobupivacaine, 2 mL of ketorolac (30 mg), and 0.5mg (0.5mL) of adrenaline, The total volume of the cocktail will be 110 mL

Procedure: Peri-articular injection group

Adductor canal block and IPACK block group

EXPERIMENTAL

Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal IPACK block in which The ultrasound probe will be positioned in the popliteal crease, and needle will be inserted into the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur and 15 ml of 0.25% Levobupivacaine will be injected

Procedure: Adductor canal block and IPACK block group

Interventions

Adductor canal block (ACB) group PROCEDURE

Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal

Adductor canal block (ACB) group

Peri-articular injection group PROCEDURE

Patients in group II will receive intraoperative peri-articular (cocktail) injection and will be performed by a single surgeon. A periarticular cocktail injection consisting of 90 mL of normal saline, 17.5 mL of 0.5% levobupivacaine, 2 mL of ketorolac (30 mg), and 0.5mg (0.5mL) of adrenaline, The total volume of the cocktail will be 110 mL

Peri-articular injection group

Adductor canal block and IPACK block group PROCEDURE

Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal IPACK block in which The ultrasound probe will be positioned in the popliteal crease, and needle will be inserted into the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur and 15 ml of 0.25% Levobupivacaine will be injected

Adductor canal block and IPACK block group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with severe osteoarthritis , ASA class I, II and III and scheduled for elective Total knee arthroplasty

You may not qualify if:

• Patient who refuse the regional anesthesia technique.
• History of allergy to local anesthetics.
• Local infection at the site of the block.
• Patients with bleeding and coagulation disorders.
• Patient with Advanced renal, hepatic and cardiac diseases.
• Preexisting lower extremity neurological abnormality, or neuropathy and difficulties in comprehending (NRS)

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta university

Tanta, Gharbia Governorate, 31528, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Population Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Mohammed S Abdelghany, Lecturer

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: * The patients will be blind through the use of closed sealed envelops. * The measurement will be collected by anesthesia nurse not participating in the study and blinded to its group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomized controlled study

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 20, 2020
• Study Start: July 1, 2020
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)