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

Post Operative Pain Clinical Trial

— TEAvsESB  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06324253
• Other study ID #: 1/24 UROL2
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: June 10, 2024

Study information

• Verified date: March 2024
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 10, 2024
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• 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
• 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

Locations

Country	Name	City	State
Egypt	Menoufia university	Cairo	Shibin Elkom

Sponsors (3)

Lead Sponsor	Collaborator
Menoufia University	Amal Ismael Abdelrahman Hassan, Ibrahim Mowafy Gomaa Atawia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The heart rate, mean arterial blood pressure	the HR and MBP will be recorded perioperative	pulse per minute--mmhge
Other	Complications like bradycardia or hypotension, intraoperative and postoperative dysrhythmia, nausea and vomiting	possible complications to the blocks wil be recorded	24 hours
Primary	Time for first rescue analgesia	the time of request of the patient of analgesia wil be recorded	24 hours
Secondary	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)	the record of patient expression to pain wil be recorded	24 hours
Secondary	the number of rescue analgesics within 24hrs after surgery	total opioid consumption	24 hours