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Completed

NCT Number: NCT06571188

Comparison of Ultrasound-Guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia

There are limited studies comparing these two modalities ( thoracic epidural and erector spine block) for relieving the pain after thoracic surgeries .this study aim to investigate this purpose

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia university

Cairo, Shibin Elkom, 23535, Egypt

About this study

The random sequence will be sealed in consecutively numbered opaque envelopes and kept by the study coordinator. Participants will be randomly divided into two groups according to the 1:1 ratio of ESPB group and TEB group. A research coordinator is designated to distribute and preserve randomization result. The coordinator will open the envelopes for allocation according to the order of enrolment and prepare the study drug.

The participants will be blinded to the allocation. Because the needle injection of ESPB and TEB are very close, participants themselves could hardly detect the clinical differences. Anaesthesiologists who perform the nerve block and take charge of intraoperative management and surgeons are independent individuals. Only the random sequence number rather than the specific nerve block type will be recorded in the electronic anaesthesia information management system .Researchers who do not take part in the nerve block and intraoperative management are designated to postoperative follow-up. Besides, trained anaesthesiologist who do not perform the block will be designated to evaluate the clinical features of the block objectively

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eligible patients will be from18-70 years old with ( American association of anaesthesiologist) ASA physical status I to III scheduled for elective thoracic surgeries.

Exclusion criteria

  • Patients who are:
  • Unable to cooperate.
  • Patients who have allergy to any of the study drugs.
  • Patients who are on opioids.
  • Local infection at the site of injection or systemic infection.
  • Patients with coagulation disorders or on anticoagulation therapy Unable to communicate preoperatively due to severe dementia, language barrier, or neuropsychiatric disorder
  • Unable to perform nerve block procedure due to difficult anatomy through ultrasound scan.

Treatment and study plan

thoracic epidural block

Other

In group TEB, The epidural catheter will be inserted preoperatively at the T5-T7 vertebral level; the exact level will be at the discretion of the attending anaesthesiologist. A loading dose of bupivacaine 0.25% (max 10 ml) will be administered, followed by an intraoperative infusion of bupivacaine 0.125 % with fentanyl 1 μg/ml.].

Other names: TEB

ERECTOER SPINE BLOCK

Other

The ESP block will be performed as described by Forero et al

Other names: ESPB

Primary outcomes

  1. MORPHINE CONSUMPTION

    Time frame: 24 hours

    cumulative 24 h opioid (morphine) consumption

  2. Numeric rating scale

    Time frame: 24 hours

    is an 11-point scale scored from 0-10:

    • "0" = no pain
    • "10" = the most intense pain imaginable Patients verbally select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours.

Secondary outcomes

  1. Time for first rescue analgesia

    Time frame: 24 hours

    Time for first rescue analgesia will be measured and recorded

  2. The number of rescue analgesics

    Time frame: 24 hours

    the number of rescue analgesics within 24hrs after surgery will be recorded

  3. Time to ambulation

    Time frame: 24 hours

    Time to ambulation WILL BE RECOREDED

  4. Complications

    Time frame: 24 hours

    Complications like bradycardia or hypotension, itching, nausea and vomiting will be recorded.

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Comparison of Ultrasound-Guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Postoperative Analgesia Following Thoracotomy Surgeries: a Randomised Trial

Acronym: TEAVSESPB

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2024
Registry last updated
Mar 20, 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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