Ultrasound-Guided Popliteal Plexus Block Versus Fascia Iliaca Block After Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

Ultrasound-Guided Popliteal Plexus Block Versus Fascia Iliaca Block for Postoperative Analgesia After Total Knee Arthroplasty: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05390450
• Other study ID #: 35431/4/22
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the effect of the Popliteal Plexus Block versus Fascia Iliaca Block on postoperative pain after total knee arthroplasty.

Description:

The Popliteal Plexus entwines the popliteal artery and vein contiguous to the adductor hiatus in the popliteal fossa and innervates the posterior capsule as well as intraarticular genicular structures. It was recently confirmed in a cadaver study that injection of 10 mL of dye into the distal end of the adductor canal spreads via the adductor hiatus to the popliteal fossa and stains the Popliteal Plexus. Recently, fascia iliaca block was proposed as a popular analgesic technique which involves local infiltration anesthesia under the fascia of the iliacus muscle. The method depends on the local anesthetics spread beneath the fascia to block the peripheral nerve. It has been proposed to avoid the complications by anesthetizing the femoral nerve remotely from major neurovascular structures and achieve adequate analgesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 40 - 75 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) score I-II.
• Scheduled for unilateral, primary TKA under spinal anesthesia.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fascia Iliaca Block
• Popliteal Plexus Block
• Total Knee Arthroplasty

Intervention

Device:
• Ultrasound-Guided Popliteal Plexus Block
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.
• Ultrasound-Guided Fascia Iliaca block
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.

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	Elgharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total intravenous (IV) morphine consumption	Total intravenous (IV) morphine consumption during the first postoperative 24 hours, postoperatively.	24 hours postoperatively.
Secondary	First analgesic request	Time to first analgesic request after surgery in the form of intravenous morphine in a dose (0.05 mg/kg).	24 hours postoperatively
Secondary	Pain level score	Pain levels using the numerical rating scale (NRS) of pain intensity (0 = no pain) to (10 = intolerable pain), pain relief is defined as a NRS of 3 or lower. If the score is >3, the patient will need analgesia in the form of morphine 0.05 mg/kg till it decreases to =3. NRS will be assessed and recorded on arrival to Post-Anesthesia Care Unit , 1, 2, 4, 8, 12 and 24 hours postoperatively at rest and on movement (knee flexion) during the first postoperative 24 hours.	24 hours postoperatively
Secondary	Rehabilitation	Rehabilitation (time to ability to sit, time to ability to stand, time to ability to walk, Time to ability to do exercise) will be recorded.	24 hours postoperatively
Secondary	Patient's satisfaction level	Degree of patient satisfaction will be assessed on a 5-point scale; (1= highly satisfied, 2 = satisfied, 3 = neither satisfied nor unsatisfied, 4 = not satisfied, 5 = highly not satisfied)	24 hours postoperatively