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Completed

NCT Number: NCT06324253

Thoracic Epidural Analgesia With Bilateral Erector Spinae Plane Block in Radical Cystectomy Surgery

The aim of this study is to compare between Thoracic Epidural Analgesia (TEA) with ultrasound-guided bilateral erector spinae plane (ESP) block in radical cystectomy surgery for analgesic efficacy and hemodynamic effects

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia university

Cairo, Shibin Elkom, Egypt

About this study

The patients will be randomly allocated into two equal groups using a computer program.

Group A: will receive bilateral Erector Spinae Block after induction of anesthesia.

Group B: will receive Thoracic Epidural Block before induction of anesthesia.

The methods:

Preoperative evaluation of each patient will include full history taking, revision of all laboratory investigations and full clinical examination.

On arrival to the operation room, a standard monitoring will be connected to the patient

In group A, after induction of anesthesia bilateral Ultrasound ESP block will be performed in the left lateral decubitus position under strict aseptic precautions. linear ultrasound transducer will be placed in a sterile cover, and positioned on the midline to identify the T10 spinous process. From this position, the ultrasound transducer will be moved 2-3 cm laterally to visualise the hyperechoic line of the T10 transverse process with its associated acoustic shadow inferiorly, and the overlying erector spinae muscle superiorly. transverse using in-plane approach a needle will be inserted in caudal-cephalad direction, until the tip is contact with the T10 transverse process and will be in the interfacial plane deep to the erector spinae muscle group. A dose of 30 ml 0.125% Bupivacaine will be injected.

In group B, before induction of anesthesia under strict aseptic precautions, 18Gauge Tuohy's needle with Huber's tip will be inserted via median approach after local infiltration with 5 ml of 2% lignocaine at the level of T9-T10 or T10-T11 intervertebral space in the sitting position. After identifying epidural space using loss of resistance technique, 5 ml of saline will be administered after negative aspiration for blood or cerebrospinal fluid and 20Gauge epidural catheter will be threaded 5 cm cranially.then will be administered a bolus dose of 10 ml of 0.125% bupivacaine through epidural catheter followed by continuous infusion of 0.125% bupivacaine at the rate of 0.1 ml/kg/hour . Patients in either group with inadequate analgesia will be excluded from the study.

General anesthesia induction will be achieved using fentanyl 1µg/kg (IV), propofol 2mg/kg (IV), and0.5mg/kg of IV Atracurium. General anesthesia will be maintained with mechanical ventilation with isoflurane (MAC 0.8: 1.2) with O2 \\ Air mixture.

During anesthesia maintenance Intraoperatively, if BP or heart rate (HR) increase more than 20% from baseline, intravenous morphine will be given to stabilize the patients' haemodynamics.

All patients will receive 1g intravenous paracetamol and 4 grams ondansetron 8mg dexamethasone.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eligible patients will be older than 40-70 years old with american society of ASA physical anesthesiologist status I, II and III scheduled for elective radical cystectomy surgeries

Exclusion criteria

  • Patients who have allergy to any of the study drugs.
  • Patients who are on opioids.
  • Known abuse of alcohol or medication.
  • Local infection at the site of injection or systemic infection.
  • Pregnancy
  • Patients with coagulation disorders or on anticoagulation therapy

Treatment and study plan

bilateral Erector spine block,A dose of 30 ml 0.125% Bupivacaine will be injected.

Procedure

will receive bilateral Erector Spinae Block after induction of anesthesia

Other names: ESB

Thoracic epidural analgesia

Procedure

will receive Thoracic Epidural Block before induction of anesthesia .a bolus dose of 10 ml of 0.125% bupivacaine through epidural catheter followed by continuous infusion of 0.125% bupivacaine at the rate of 0.1 ml/kg/hour

Other names: TEA

Primary outcomes

  1. Time for first rescue analgesia

    Time frame: 24 hours

    the time of request of the patient of analgesia wil be recorded

Secondary outcomes

  1. Visual analogue scale score at 1st,2nd,4th,6th,8th,12th and 24 h (where 0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain)

    Time frame: 24 hours

    the record of patient expression to pain wil be recorded

  2. the number of rescue analgesics within 24hrs after surgery

    Time frame: 24 hours

    total opioid consumption

Other outcomes

  1. The heart rate, mean arterial blood pressure

    Time frame: pulse per minute--mmhge

    the HR and MBP will be recorded perioperative

  2. Complications like bradycardia or hypotension, intraoperative and postoperative dysrhythmia, nausea and vomiting

    Time frame: 24 hours

    possible complications to the blocks wil be recorded

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Collaborators

  • Amal Ismael Abdelrahman Hassan
  • Ibrahim Mowafy Gomaa Atawia

Registry information

Official study title

Comparison of Thoracic Epidural Analgesia With Ultrasound-Guided Bilateral Erector Spinae Plane Block in Radical Cystectomy Surgery: A Randomised Trial

Acronym: TEAvsESB

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 21, 2024
Registry last updated
Mar 3, 2026

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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