- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06265441
Comparison of Pain Relief Post Knee Arthroscopy Using IPACK + Adductor Canal Block Vs. Adductor Canal Block Alone
November 4, 2024 updated by: Ain Shams University
Comparison of IPACK Block with Adductor Canal Block Vs Adductor Canal Block Alone for Post Operative Analgesia Following Arthroscopic Knee Surgeries
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- 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
- Procedure: 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%
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Abbassia
-
Cairo, Abbassia, Egypt, 00202
- Ain Shams University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Physical status: ASA 1 or 2
- Age group: 21-40 years.
- No sex predilection.
- Patients undergoing arthroscopic knee surgery under spinal anesthesia.
Exclusion Criteria:
- Patient refusal
- Physical status: ASA III or above.
- Patients with contraindications for spinal anesthesia.
- Patients with history of drug allergies to study drugs.
- Evidence of local infection at site of injection.
- Neuromuscular pathology (example: - Multiple Sclerosis)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A : Adductor canal block only
Patients will receive Adductor canal block under ultrasound guide of 20 ml bupivacaine 0.25%
|
The patients in group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance (SonoSite™, Inc., Bothell, WA 98021, USA) in which the patients are placed in the supine position with the arms resting comfortably across the chest and the affected lower extremity is externally rotated.
Adductor canal was identified beneath the sartorius muscle and 22-gauge 90-mm spinal needle is inserted from anterolateral to posteromedial direction at a point approximately at the junction between the middle and distal third of the thigh on the anteromedial femur, this location is called mid adductor canal, then 20 ml of 0.25% bupivacaine is injected in the canal
|
|
Active Comparator: Group B : Adductor canal + IPACK block
Patients will receive Adductor canal block and IPACK block under ultrasound guidance with 20 ml bupivacaine 0.25% for each block
|
The patients in Group B will receive adductor canal block as described in group A then IPACK block, in which the patients are 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 1 finger breadth above the patella, 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 while the needle is being withdrawn after negative aspiration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of pain using the visual analogue scale (VAS) at 2 hours, 4 hours, 6 hours, and 8 hours after the completion of the surgical procedure and skin closure.
Time Frame: 8 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total pethidine consumption
Time Frame: 24 hours
|
Total pethidine consumption (in mg.) over 24-hour period post-operative
|
24 hours
|
|
The time till first analgesic requirement
Time Frame: as requested by patient
|
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 pethidine (30mg) when VAS > 4 at any time of assessment)
|
as requested by patient
|
|
The number of steps
Time Frame: 24 hours
|
ambulation distance assessed by the number of steps walked by the patient 24 hours after the surgery
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed Morsi, M.B.B.CH, Anesthesia resident, Ain shams university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2024
Primary Completion (Actual)
September 1, 2024
Study Completion (Actual)
October 1, 2024
Study Registration Dates
First Submitted
February 7, 2024
First Submitted That Met QC Criteria
February 16, 2024
First Posted (Actual)
February 20, 2024
Study Record Updates
Last Update Posted (Estimated)
November 5, 2024
Last Update Submitted That Met QC Criteria
November 4, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS42/2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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