Post Operative PainTEAvsESBNCT06324253
Thoracic Epidural Analgesia With Bilateral Erector Spinae Plane Block in Radical Cystectomy Surgery
A study testing bilateral Erector spine block,A dose of 30 ml 0.125% Bupivacaine will be injected. and Thoracic epidural analgesia in people with Post Operative Pain, run by Menoufia University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- bilateral Erector spine block,A dose of 30 ml 0.125% Bupivacaine will be injected. and Thoracic epidural analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2024to 10 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Thoracic Epidural Analgesia With Ultrasound-Guided Bilateral Erector Spinae Plane Block in Radical Cystectomy Surgery: A Randomised Trial
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
Read the 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
- Being tested
- bilateral Erector spine block,A dose of 30 ml 0.125% Bupivacaine will be injected., Thoracic epidural analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral Erector spine block,A dose of 30 ml 0.125% Bupivacaine will be injected.Procedure or surgery
Also called ESB
will receive bilateral Erector Spinae Block after induction of anesthesia
Thoracic epidural analgesiaProcedure or surgery
Also called TEA
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Thoracic epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for first rescue analgesia
the time of request of the patient of analgesia wil be recorded
Measured: 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)
the record of patient expression to pain wil be recorded
Measured: 24 hours
the number of rescue analgesics within 24hrs after surgery
total opioid consumption
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start30 Mar 2024
- Primary completion10 May 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Collaborators
- Amal Ismael Abdelrahman Hassan, Ibrahim Mowafy Gomaa Atawia
- Responsible party
- Principal investigator, Amal Gouda Elsayed Safan, Menoufia University
- Investigators
- AMAL G SAFAN, MD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324253
- Sponsor's protocol ID
- 1/24 UROL2
- Acronym
- TEAvsESB
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Thoracic Epidural Analgesia With Ultrasound-Guided Bilateral Erector Spinae Plane Block in Radical Cystectomy Surgery: A Randomised Trial
- ClinicalTrials.gov ID
- NCT06324253
- Acronym / sponsor ID
- TEAvsESB / 1/24 UROL2
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Collaborators
- Amal Ismael Abdelrahman Hassan, Ibrahim Mowafy Gomaa Atawia
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Block | Active comparator | Procedure: bilateral Erector spine block,A dose of 30 ml 0.125% Bupivacaine will be injected.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 |
| Thoracic Epidural Block | Active comparator | Procedure: Thoracic epidural analgesiabefore 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bilateral Erector spine block,A dose of 30 ml 0.125% Bupivacaine will be injected.Also: ESBwill receive bilateral Erector Spinae Block after induction of anesthesia | Procedure or surgery | Erector Spinae Block |
| Thoracic epidural analgesiaAlso: TEAwill 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 | Procedure or surgery | Thoracic Epidural Block |
Primary outcome
Time for first rescue analgesia
Time frame: 24 hours
the time of request of the patient of analgesia wil be recorded
2 secondary outcomes
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 number of rescue analgesics within 24hrs after surgery
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AMAL G SAFAN, MD principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral Erector spine block,A dose of 30 ml 0.125% Bupivacaine will be injected. and Thoracic epidural analgesia in people with Post Operative Pain, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for first rescue analgesia (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.