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Enrolling by Invitation

NCT Number: NCT06562634

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

To estimate the efficacy of the ultrasound guided ESP block for postoperative pain control in open knee surgeries under general anesthesia.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

erector spinea plane block

Procedure

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.

Morphine sulfate

Drug

intravenous morphine will be given in a dose of 0.1-0.2mg/kg to maintain intraoperative analgesia.

Primary outcomes

  1. Total morphine consumption during the 1st 24 h postoperative.

    Time frame: 24 hour postoperative

    Total morphine consumption during the 1st 24 h postoperative.

Secondary outcomes

  1. Intraoperative fentanyl consumption

    Time frame: Intraoperative

  2. Time to first postoperative analgesic request

    Time frame: 24hour postoperative

  3. Visual analogue score (0-10)

    Time frame: 24hour postoperative

    0: no pain 10:worst pain

  4. Hemodynamics :heart rate (bpm)

    Time frame: baseline ,Intraoperative every 15 min, postoperative for 24 hr

  5. Block failure rate.

    Time frame: Intraoperative &24 hour postoperative

  6. Incidence of complications. (Nerve injury, Hematoma formation, LA toxicity, Intravascular injection

    Time frame: 24hour postoperative

  7. Hemodynamics :arterial blood pressure (systolic, diastolic and mean blood pressure) in mmhg

    Time frame: baseline, intraoperative every 15 min, postoperative for 24 hr

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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