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

Postoperative Pain Clinical Trial

Official title:

Comparison of Adductor Canal Block, Peri-articular Injection or Infiltration Between Popliteal Artery and Posterior Knee Capsule (IPACK) With Adductor Canal Block in Total Knee Arthroplasty.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04396652
• Other study ID #: 33748/3/20
• Secondary ID: Tanta University
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: October 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Regional Anesthesia

Intervention

Procedure:
• 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
• 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
• 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

Locations

Country	Name	City	State
Egypt	Tanta university	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative analgesia	Total analgesic consumption will be recorded	First 24 hours postoperatively
Secondary	Duration of the block	Time till administration of first rescue analgesia will be recorded	First 24 hours postoperatively
Secondary	Effect on Motor function	By recording the mean time taken to achieve 90o active knee flexion	Each day till the third postoperative day