Clinical trial NCT06324253: Thoracic Epidural Analgesia With Bilateral Erector Spinae Plane Block in Radical Cystectomy Surgery
Official title: Comparison of Thoracic Epidural Analgesia With Ultrasound-Guided Bilateral Erector Spinae Plane Block in Radical Cystectomy Surgery: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Menoufia University
Sponsor class: OTHER
Collaborators: name: Amal Ismael Abdelrahman Hassan
name: Ibrahim Mowafy Gomaa Atawia
First posted: 2024-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: will receive bilateral Erector Spinae Block after induction of anesthesia.

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

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.

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

Primary outcomes:
measure: Time for first rescue analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: 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)
timeFrame: 24 hours
measure: the number of rescue analgesics within 24hrs after surgery
timeFrame: 24 hours
Other outcomes:
measure: The heart rate, mean arterial blood pressure
timeFrame: pulse per minute--mmhge
measure: Complications like bradycardia or hypotension, intraoperative and postoperative dysrhythmia, nausea and vomiting
timeFrame: 24 hours
Locations:
city: Cairo
country: Egypt
facility: Menoufia university
state: Shibin Elkom
Study officials:
affiliation: Menoufia University
name: AMAL G SAFAN, MD
role: PRINCIPAL_INVESTIGATOR
References: