NCT05390450

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

May 18, 2022

Last Update Submit

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

EXPERIMENTAL

Patients in this group will receive Popliteal plexus block.

Device: Ultrasound-Guided Popliteal Plexus Block

Ultrasound-Guided Fascia Iliaca block

EXPERIMENTAL

Patients in this group will receive Fascia Iliaca block.

Device: Ultrasound-Guided 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.

Ultrasound-Guided Popliteal Plexus 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.

Ultrasound-Guided Fascia Iliaca block

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Tanta University Hospitals

Tanta, Elgharbia, 31527, Egypt

Location

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

The protocol will available under reasonable request from the corresponding author.

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.

Locations