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

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05390450
Collaborator
(none)
60
2
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ultrasound-Guided Popliteal Plexus Block
  • Device: Ultrasound-Guided Fascia Iliaca block
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ultrasound-Guided Popliteal Plexus Block Versus Fascia Iliaca Block for Postoperative Analgesia After Total Knee Arthroplasty: A Randomized Clinical Trial
Anticipated Study Start Date :
May 30, 2022
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ultrasound-Guided Popliteal Plexus Block

Patients in this group will receive Popliteal plexus block.

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.

Experimental: Ultrasound-Guided Fascia Iliaca block

Patients in this group will receive Fascia Iliaca block.

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. Total intravenous (IV) morphine consumption [24 hours postoperatively.]

    Total intravenous (IV) morphine consumption during the first postoperative 24 hours, postoperatively.

Secondary Outcome Measures

  1. First analgesic request [24 hours postoperatively]

    Time to first analgesic request after surgery in the form of intravenous morphine in a dose (0.05 mg/kg).

  2. Pain level score [24 hours postoperatively]

    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.

  3. Rehabilitation [24 hours postoperatively]

    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.

  4. Patient's satisfaction level [24 hours postoperatively]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taysser Mahmoud Abdalraheem, Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University
ClinicalTrials.gov Identifier:
NCT05390450
Other Study ID Numbers:
  • 35431/4/22
First Posted:
May 25, 2022
Last Update Posted:
May 27, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 27, 2022