Completed

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.

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What is being tested

Adductor canal block (ACB) group

+ Peri-articular injection group

+ Adductor canal block and IPACK block group

Procedure
Who is being recruted

Neurologic Manifestations+4

+ Pain

+ Pain, Postoperative

From 30 to 70 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: July 2020
See protocol details

Summary

Principal SponsorTanta University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2020

Actual date on which the first participant was enrolled.

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.

Official TitleComparison 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.
NCT04396652
Principal SponsorTanta University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

1 inclusion criteria required to participate
Adult patients with severe osteoarthritis , ASA class I, II and III and scheduled for elective Total knee arthroplasty

6 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Tanta university

Tanta, EgyptOpen Tanta university in Google Maps
CompletedOne Study Center