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

NCT ID: NCT04396652

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-09-15

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

Detailed Description

This prospective randomized study will be carried out in Tanta University Hospitals in Anesthesia Department for one year after approval from ethical committee of faculty of medicine of Tanta university. After approval from institutional ethics committee, an informed consent will be taken from each patient. All data of the patients will be confidential with secret codes and private file for each patient, all given data will be used for the current medical research only. Any unexpected risks encountered during the course of the research will be cleared to the participants as well as to the Ethical Committee on time. Every patient will receive an explanation to the purpose of the study and every patient will have a secret code number to ensure privacy to participants and confidentiality of data.

Inclusion criteria:

Adult patients with severe osteoarthritis , ASA class I, II and III and scheduled for elective Total knee arthroplasty will be enrolled in the study.

Exclusion criteria:

• 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).

Grouping and Allocation:

60 patients will be enrolled in this study in each group, Patients will be randomly classified into three equal groups (20 patients each).

Randomization will be done by computer generated numbers into:

Group (I): 20 patients will receive adductor canal block alone. Group (II): 20 Patients will receive peri-articular injection alone. Group (III): 20 patients will receive adductor canal block (ACB) and infiltration of the interspace between popliteal artery and the capsule of posterior knee block (IPACK).

Anesthetic technique:

Preoperative assessment will be done by:

History talking, clinical examination, routine laboratory investigations including CBC, coagulation profile, random blood sugar, liver and renal function tests. During the pre-anesthetic assessment, all patients will be familiarized with Numeric Rating Scale (NRS) score. On entering the operating room, intravenous line (IV) will be inserted, routine monitoring of heart rate by ECG, noninvasive blood pressure (NIBP), pulse oximetry will be done. All patients will receive spinal anesthesia with 3 ml 0.5% (15 mg) hyperbaric bupivacaine plus 25 μgm fentanyl at the L3/4 interspaces and the study of regional anesthetic technique will be performed postoperatively according to each group. All patients will receive postoperative analgesic regimen which is paracetamol 1gm intravenously every 8 hours and ketorolac 30mg every12 hours. Rescue analgesia in the form of 0.05 mg/kg of morphine IV will be administrated when the Numeric Rating Score (NRS) exceeding 3. The morphine dose will be repeated whenever indicated considering the total dose in the first 24 hours never exceeding 20 mg.

Measurements:

1. Demographic data (age, gender, weight, ASA classification).

2. Post-operative pain will be assessed by Numeric Rating Scale (NRS) from 0 to 10 at 0,2,4,6 then every 6h for 24 hours and in the second and third postoperative days at rest and during Physiotherapy.

3. Postoperative analgesia, which will be assessed by total analgesic consumption, and time till administration of first rescue analgesia will be recorded.

4. Effect on Motor function: by recording the mean time taken to achieve 90o active knee flexion each day till the third postoperative day.

5. Adverse effects: hypotension, Bradycardia, infection, hematoma and local anesthetic toxicity will be observed and treated accordingly.

Conditions

Postoperative Pain; Regional Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Adductor canal block (ACB) group

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

Group Type: EXPERIMENTAL

Adductor canal block (ACB) group

Intervention Type: 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

Peri-articular injection group

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

Group Type: EXPERIMENTAL

Peri-articular injection group

Intervention Type: 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

Adductor canal block and IPACK block group

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

Group Type: EXPERIMENTAL

Adductor canal block and IPACK block group

Intervention Type: 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

Interventions

Adductor canal block (ACB) group

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

Intervention Type: PROCEDURE

Peri-articular injection group

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

Intervention Type: PROCEDURE

Adductor canal block and IPACK block group

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Shebl Abdelghany

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed S Abdelghany, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Tanta university

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

Tanta University

Identifier Type: OTHER

Identifier Source: secondary_id

33748/3/20

Identifier Type: -

Identifier Source: org_study_id