Ultrasound-Guided Popliteal Plexus Block Versus Fascia Iliaca Block After Total Knee Arthroplasty
1 other identifier
interventional
60
1 country
1
Brief Summary
This study aims to investigate the effect of the Popliteal Plexus Block versus Fascia Iliaca Block on postoperative pain after total knee arthroplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedApril 21, 2023
April 1, 2023
10 months
May 18, 2022
April 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Total intravenous (IV) morphine consumption
Total intravenous (IV) morphine consumption during the first postoperative 24 hours, postoperatively.
24 hours postoperatively.
Secondary Outcomes (4)
First analgesic request
24 hours postoperatively
Pain level score
24 hours postoperatively
Rehabilitation
24 hours postoperatively
Patient's satisfaction level
24 hours postoperatively
Study Arms (2)
Ultrasound-Guided Popliteal Plexus Block
EXPERIMENTALPatients in this group will receive Popliteal plexus block.
Ultrasound-Guided Fascia Iliaca block
EXPERIMENTALPatients in this group will receive Fascia Iliaca block.
Interventions
Patients in this group will receive Popliteal plexus block. Prior to Popliteal plexus block, the proximal end of the adductor canal will be identified. The transducer will be slid distally along the femoral artery until the artery deviated away from the sartorius muscle in the distal part of the adductor canal towards the adductor hiatus. The nerve block needle will be inserted from the anterolateral end of the transducer and advanced in-plane through the medial vastus muscle. The endpoint of injection will be inside the distal end of the adductor canal close to the adductor hiatus. The injection will be adjacent to the femoral artery, between the medial vastus muscle and the adductor magnus muscle. The Popliteal plexus block will be carried out with 10 mL of local anesthetic mixture, containing 50 mg of bupivacaine and 0.05 mg of epinephrine.
Patients will be placed in a supine position, and the skin will be cleaned aseptically. The inguinal ligament from the anterior superior iliac spine to the pubic tubercle will be drawn on the skin and divided into 3 parts. The injection point was 1 cm caudally from the point where the lateral and middle part of the inguinal ligament met. The skin and deep tissues were infiltrated with 1% lidocaine. A 18G nerve block needle will be inserted into the skin perpendicularly until the first (fascia lata) and second loss of resistance (fascia iliaca) will be felt. Following aspiration to exclude intravascular injection, 40 mL of 0.25% bupivacaine (1-1.5 mg/kg), which will be prepared under aseptic conditions, and then injected. Sensorial block will be evaluated using the pinprick test 20 minutes after injection for areas of the thigh innervated by the femoral, lateral cutaneous and obturator nerves.
Eligibility Criteria
You may qualify if:
- Age 40 - 75 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) score I-II.
- Scheduled for unilateral, primary TKA under spinal anesthesia.
You may not qualify if:
- Coagulopathy.
- Diabetes.
- Obesity.
- Heart failure.
- kidney failure.
- Liver failure.
- Reduced sensation on the lower limb.
- Daily intake of opioids.
- Contraindication to any drug used in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta University Hospitals
Tanta, Elgharbia, 31527, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine
Study Record Dates
First Submitted
May 18, 2022
First Posted
May 25, 2022
Study Start
June 1, 2022
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
April 21, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- One year after the end of the study.
- Access Criteria
- The protocol will available under reasonable request from the corresponding author.
The protocol will available under reasonable request from the corresponding author.