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

NCT ID: NCT06324253

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-06-10

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

Detailed Description

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Erector Spinae Block

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

will receive bilateral Erector Spinae Block after induction of anesthesia

Thoracic Epidural Block

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

Group Type: ACTIVE_COMPARATOR

Thoracic epidural analgesia

Intervention Type: 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

Interventions

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

will receive bilateral Erector Spinae Block after induction of anesthesia

Intervention Type: PROCEDURE

Thoracic epidural analgesia

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

Intervention Type: PROCEDURE

Other Intervention Names

ESB; TEA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amal Ismael Abdelrahman Hassan

UNKNOWN

Sponsor Role: collaborator

Ibrahim Mowafy Gomaa Atawia

UNKNOWN

Sponsor Role: collaborator

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Amal Gouda Elsayed Safan

lecturer of anaethesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AMAL G SAFAN, MD

Role: PRINCIPAL_INVESTIGATOR

Menoufia University

Locations

Menoufia university

Cairo, Shibin Elkom, Egypt

Countries

Egypt

Other Identifiers

1/24 UROL2

Identifier Type: -

Identifier Source: org_study_id