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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06265441
Other study ID # MS42/2024
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date October 1, 2024

Study information

Verified date February 2024
Source Ain Shams University
Contact Mohamed Morsi, M.B.B.CH
Phone +201116618163
Email MohamedMorsi@med.asu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, the invistigators aim to compare postoperative analgesia effectiveness between combined interspace between the popliteal artery and posterior capsule of the knee block (IPACK) and Adductor canal block vs. Adductor canal block alone after Arthroscopic knee surgeries focusing on VAS score assessment at 8 hours postoperative.


Description:

Patients who fulfilled the inclusion criteria and agreed to participate in the study will be randomly divided into two groups using their computer-generated random numbers such that even numbers will be enrolled in group A for Adductor canal block alone and odd numbers will be enrolled in group B for Adductor canal block and IPACK block.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date October 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Physical status: ASA 1 or 2 and candidates for spinal anesthesia undergoing Arthroscopic knee surgery. - Age group: 20-40 years. - No sex predilection. Exclusion Criteria: - Patient refusal - Physical status: ASA III or above. - Patients with contraindications for spinal anaesthesia. - Patients with history of drug allergies to study drugs. - Evidence of local infection at site of injection. - Neuromuscular pathology (example: - Multiple Sclerosis)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance in which the adductor canal is identified and 20 ml of 0.25% bupivacaine will be injected
Patients will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance in which the adductor canal is identified beneath the sartorius muscle and 20 ml of 0.25% bupivacaine will be injected in the canal using a 22-gauge 100-mm short-bevelled regional block needle
Group B will receive adductor canal block under ultrasound guide 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound of 20 ml bupivacaine 0.25%
Group B will receive Adductor canal block as described then IPACK in which the patient is placed in a supine position and knee is placed in position of 90° flexion. A low-frequency ultrasound probe is positioned in the popliteal crease, and a spinal needle is inserted from the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle is placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.25% bupivacaine is injected after negative aspiration.

Locations

Country Name City State
Egypt Ain Shams University Cairo Abbassia

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of pain using the visual analogue scale (VAS) upon first ambulation after 8 hours from the completion of the surgical procedure and skin closure. Visual analogue scale (VAS) (scale 0-10, where 0 = no pain and 10 = worst imaginable pain). All the patients will have the VAS score explained and taught for self-assessment of pain at the time of enrolment for the study. 8 hours
Secondary Total analgesics consumption Total analgesics consumption (in mg.) over 24-hour period post-operative 24 hours
Secondary The time till first analgesic requirement The time (in hours) after finishing of ultrasound guided IPACK or Adductor canal blocks till the patient's requirement for first analgesia postoperative in ward. (All patients will receive intravenous morphine (3mg)/pethidine (30mg) on demand with paracetamol IV/8 hours.) as requested by patient
Secondary The range of movement (ROM) The range of movement (ROM) by assessing the degree of knee extension one day after the surgery 3 days
Secondary The number of steps ambulation distance assessed by the number of steps walked by the patient three days after the surgery 3 days
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