Effectiveness of Ultrasound-Guided Erector Spinae Plane Block for Postoperative Pain Control in Open Knee Surgeries

February 13, 2025 updated by: Noha Sameh Darwish, Cairo University
To estimate the efficacy of the ultrasound guided ESP block for postoperative pain control in open knee surgeries under general anesthesia.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain is a major concern after knee surgeries. It is severe in 60% of patients and moderate in 30%. When inadequately treated, it intensifies reflex responses, which leads to cause serious complications, such as cardiovascular, pulmonary or urinary problems, thromboembolism, increased oxygen consumption, hyperdynamic circulation and hinders early physical therapy. Generally it has been assumed that adequate postoperative pain relief may reduce these complications, and improve general postoperative outcome.

In the last decade Improvements in pain management techniques have had a major impact on the practice of knee surgeries. Although there are a number of treatment options for postoperative pain, a gold standard has not been established. Patient-controlled analgesia (PCA), epi¬dural analgesia and lumbar plexus and/or sciatic blocks are the commonly used routes for pain relief after joint surgery .Each of those options has advantages and disadvantages. PCA has fewer technical problems, uniform and sustained analgesia with autonomy, however it might lead to respiratory depression, nausea and vomiting. Epidural analgesia is an efficient route for postoperative analgesia ; however it is associated with technical failures, hypotension, urinary retention, and ileus, motor block that limits ambulation, unrecognized compartment syndromes, and spinal hematoma secondary to anticoagulation.

The ultrasound-guided erector spinae plane (ESP) block is a recently described regional anesthetic technique for providing thoracic analgesia when performed at the level of T5 transverse process. Local anesthetic is injected into the fascial plane deep to the erector spinae muscle, and spreads craniocaudally over several levels can lead to effective analgesia and sensory block from T2 to T9. Local anesthetic also penetrates anteriorly through the intertransverse connective tissue and enters the thoracic paravertebral space where it can potentially block not only the ventral and dorsal rami of spinal nerves but also the rami communicantes that transmit sympathetic fibers.

ESP advantages include its simplicity, easy identifiable ultrasonographic landmarks and an endpoint for injection and low risk for serious complications as injection is into tissue plane that is distant from pleura, major blood vessels and discrete nerves.

There is clinical report of two cases shows the ESP block may be a safe, simple and effective technique for analgesia following surgery around the knee.

However, confirmation of the efficacy of ESP block in knee surgeries needs more investigation.

Study Type

Interventional

Enrollment (Estimated)

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

  • Egypt
      • Cairo, Egypt
        • Kasr Alainy

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • Patients aged from 18 to 60 years old.

    • Genders eligible for study: both sexes.
    • ASA I-II.
    • Undergo knee surgery.
    • BMI from 18 to 35 kg/m2.

Exclusion Criteria:

  • • Patient refusal.

    • Patients with difficulty in evaluating their level of pain.
    • Contraindications to regional anesthesia (Bleeding disorders e.g. INR>1.5, PC<70%, platelet count<100 × 109, Use of any anti-coagulants, local infection, etc.).
    • Known allergy to local anesthetics.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound-Guided Erector Spinae Plane Block
The patient will be placed in a prone position. A convex-array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process .The tip of the transverse process is centered on the ultrasound screen and the probe is then rotated into a longitudinal orientation 2-3 cm lateral to vertebral column, in which the following layers will be visible superficial to the acoustic shadows of the transverse processes: skin, subcutaneous tissue, erector spinae muscle and psoas muscle. The lumbar skin region will be sterilized, local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle is inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact was made with the L4 transverse process. A total of 20ml bupivicaine 0.25%, and 20 ml xylocaine 1% will be injected into the ESP on the affected side.
Procedure: erector spinea plane block
an echogenic 22-G block needle is inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact was made with the L4 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle is confirmed by injecting 0.5-1 ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total of 20ml bupivicaine 0.25%, and 20 ml xylocaine 1% will be injected into the ESP on the affected side.
Experimental: Morphine
intravenous morphine will be given in a dose of 0.1-0.2mg/kg to maintain intraoperative analgesia.
Drug: Morphine Sulfate
intravenous morphine will be given in a dose of 0.1-0.2mg/kg to maintain intraoperative analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine consumption during the 1st 24 h postoperative.
Time Frame: 24 hour postoperative
Total morphine consumption during the 1st 24 h postoperative.
24 hour postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative fentanyl consumption
Time Frame: Intraoperative
Intraoperative
Time to first postoperative analgesic request
Time Frame: 24hour postoperative
24hour postoperative
Visual analogue score (0-10)
Time Frame: 24hour postoperative
0: no pain 10:worst pain
24hour postoperative
Hemodynamics :heart rate (bpm)
Time Frame: baseline ,Intraoperative every 15 min, postoperative for 24 hr
baseline ,Intraoperative every 15 min, postoperative for 24 hr
Block failure rate.
Time Frame: Intraoperative &24 hour postoperative
Intraoperative &24 hour postoperative
Incidence of complications. (Nerve injury, Hematoma formation, LA toxicity, Intravascular injection
Time Frame: 24hour postoperative
24hour postoperative
Hemodynamics :arterial blood pressure (systolic, diastolic and mean blood pressure) in mmhg
Time Frame: baseline, intraoperative every 15 min, postoperative for 24 hr
baseline, intraoperative every 15 min, postoperative for 24 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

March 1, 2025

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 18, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESPB in knee surgeries

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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