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

NCT06324253 | Completed

• 1 other identifier: 1/24 UROL2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Time for first rescue analgesia

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

  24 hours

Secondary Outcomes (2)

• 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)

  24 hours

• the number of rescue analgesics within 24hrs after surgery

  24 hours

Other Outcomes (2)

• The heart rate, mean arterial blood pressure

  pulse per minute--mmhge

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

  24 hours

Study Arms (2)

Erector Spinae Block

ACTIVE COMPARATOR

after induction of anesthesia bilateral US 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. 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 and A dose of 30 ml 0.125% Bupivacaine will be injected bilateral in this plane . All patients will receive 1g intravenous paracetamol and 4 grams ondansetron 8mg dexamethasone

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

Thoracic Epidural Block

ACTIVE COMPARATOR

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. the patients in group B will be administered with 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 All patients will receive 1g intravenous paracetamol and 4 grams ondansetron 8mg dexamethasone

Procedure: Thoracic epidural analgesia

Interventions

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

Also known as: ESB

Erector Spinae Block

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

Also known as: TEA

Thoracic Epidural Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Menoufia University: lead
• Amal Ismael Abdelrahman Hassan: collaborator
• Ibrahim Mowafy Gomaa Atawia: collaborator

Study Sites (1)

Menoufia university

Cairo, Shibin Elkom, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tea

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• AMAL G SAFAN, MD

  Menoufia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anaethesia

Model Details: Group A: will receive bilateral Erector Spinae Block after induction of anesthesia. Group B: will receive Thoracic Epidural Block before induction of anesthesia.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: March 21, 2024
• Study Start: March 30, 2024
• Primary Completion: May 10, 2024
• Study Completion: June 10, 2024
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

EG (1)