Cancer, BladderNCT05278598
3 Ultrasound Guided Plane Blocks for Perioperative Analgesia in Patients Undergoing Radical Cystectomy
A study testing Erector Spinae Plane Block, Thoracic Paravertebral Plane Block and Quadratus Lumborum Plane Block in people with Cancer, Bladder and Surgery, run by Nazmy Edward Seif at 1 site in Egypt.
Trial summary
Radical cystectomy is the gold standard treatment for muscle invasive bladder cancer as well as some T1 and non-invasive disease. It is a major operation with significant perioperative morbidity and complications. Pain is one of the most important complications to be managed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Bladder, Surgery, Anesthesia
- What is being tested?
- Erector Spinae Plane Block, Thoracic Paravertebral Plane Block and Quadratus Lumborum Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Mar 2022to 16 Aug 2023
- 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
- American Society of Anesthesiologists (ASA) class II - III.
- Adult patients scheduled for radical cystectomy.
Who cannot join
- Patient refusal.
- Uncooperative patients.
- Patients with known allergies to local anesthetics.
- Bleeding disorders or coagulopathy.
- Anatomical abnormality or infection at injection site.
- Patients receiving opioids for chronic analgesic therapy.
- Spinal anesthesia or any other regional anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Assessment of 3 Ultrasound Guided Plane Blocks for Perioperative Analgesia in Patients Undergoing Radical Cystectomy: A Randomized Clinical Trial
Radical cystectomy is the gold standard treatment for muscle invasive bladder cancer as well as some T1 and non-invasive disease. It is a major operation with significant perioperative morbidity and complications. Pain is one of the most important complications to be managed.
Regional blocks as a part of multi-modal analgesia are considered main strategies of Enhanced Recovery after Surgery (ERAS) decreasing post-operative complications including post-operative pain and post-operative hospital stay. They also have an upper hand over systemic intravenous opioids decreasing the risk for post-operative delirium specially in old age patients. Thoracic paravertebral plane block (TPVPB), intra muscular quadratus lumborum plane block (QLPB) and erector spinae plane block (ESPB) are among these regional anesthesia techniques for pain management.
Read more
Erector spinae plane block is an emerging block, with low risk and more feasibility, but efficacy hasn't been compared to quadratus lumborum and paravertebral plane blocks altogether in radical cystectomy surgeries.
All these blocks are effective in reducing postoperative pain and the need of analgesia in radical cystectomy surgery; this is a comparative study between the three blocks in this population.
- Conditions
- Cancer, Bladder, Surgery, Anesthesia, Analgesia, Block
- Being tested
- Erector Spinae Plane Block, Thoracic Paravertebral Plane Block, Quadratus Lumborum Plane Block
- Keywords
- Erector spinae plane block, Quadratus lumborum plane block, Paravertebral block, Ultrasound-guided, Radical cystectomy, Analgesia, Anesthesia
- Medical subject headings
- Urinary Bladder Neoplasms, Agnosia, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
After skin sterilization, ESP block will be performed at the level of T9. A curvilinear high-frequency ultrasound transducer will be placed sagittal 3 cm lateral to T9 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 30 mL of 0.25% bupivacaine will be injected. Sonographic confirmation of the local anesthetic spread will be seen as an anechoic shadow in the paravertebral spaces from T7 to T12.
This procedure will be done on both sides.
Thoracic Paravertebral Plane BlockProcedure or surgery
After skin sterilization, curvilinear high-frequency ultrasound transducer will be used to visualize the T10 paravertebral space in the paramedian sagittal plane. An injection into the paravertebral space will spread to multiple adjacent dermatomes, so exact identification of a specific level will be not necessary. A 22-gauge spinal needle will be inserted in-plane relative to the ultrasound probe and slowly be directed from lateral to medial until its tip was located at the apex of the paravertebral space and the endpoint for successful block will be anterior displacement of the pleura by injected local anesthetic where a single injection of 30 ml of 0.25% bupivacaine will be injected.
This procedure will be done on both sides.
Quadratus Lumborum Plane BlockProcedure or surgery
After skin sterilization, curvilinear high-frequency ultrasound transducer will be positioned horizontally in the anterior axillary line halfway between the subcostal margin and iliac crest, to locate the triple abdominal muscle layers, then the probe will be relocated subsequently to the posterior axillary line until the quadratus lumborum muscle could be visualized with its attachment to the lateral edge of the transverse process of the L4 vertebral body. With the psoas major muscle anteriorly, the erector spinae muscle posteriorly and the quadratus lumborum muscle adherent to the apex of the transverse process, this is a well-recognizable pattern of a shamrock with three leaves. A 22-gauge spinal needle will be inserted in-plane relative to the ultrasound probe passing in posterior to anterior direction through the quadratus lumborum to reach the border between it and psoas major, where 30 ml of 0.25% bupivacaine will be injected.
This procedure will be done on both sides.
| Study group | Role | What they receive |
|---|---|---|
| ESPB group | Active comparator | Erector Spinae Plane Block Receives: Procedure: Erector Spinae Plane Block |
| TPVPB group | Active comparator | Thoracic Paravertebral Plane Block Receives: Procedure: Thoracic Paravertebral Plane Block |
| QLPB group | Active comparator | Quadratus Lumborum Plane Block Receives: Procedure: Quadratus Lumborum Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption.
Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.
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 posted14 Mar 2022
- Study start27 Mar 2022
- Primary completion16 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BladderStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nazmy Edward Seif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazmy Edward Seif, Cairo University
- Investigators
- Moustafa M Zalat, MSc, Principal investigator, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo UniversityNazmy S Michael, MD, Study director, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278598
- Sponsor's protocol ID
- 3USGPBPORC
- Status last verified
- May 2024
- First submitted
- 4 Mar 2022
- Last updated
- 8 May 2024
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of 3 Ultrasound Guided Plane Blocks for Perioperative Analgesia in Patients Undergoing Radical Cystectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05278598
- Acronym / sponsor ID
- 3USGPBPORC
- Conditions
- Cancer, Bladder, Surgery, Anesthesia, Analgesia, Block
- Keywords
- Erector spinae plane block, Quadratus lumborum plane block, Paravertebral block, Ultrasound-guided, Radical cystectomy, Analgesia, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nazmy Edward SeifUniversity, hospital or other
- Study start
- 27 Mar 2022 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 14 Mar 2022 (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.
Radical cystectomy is the gold standard treatment for muscle invasive bladder cancer as well as some T1 and non-invasive disease. It is a major operation with significant perioperative morbidity and complications. Pain is one of the most important complications to be managed.
Regional blocks as a part of multi-modal analgesia are considered main strategies of Enhanced Recovery after Surgery (ERAS) decreasing post-operative complications including post-operative pain and post-operative hospital stay. They also have an upper hand over systemic intravenous opioids decreasing the risk for post-operative delirium specially in old age patients. Thoracic paravertebral plane block (TPVPB), intra muscular quadratus lumborum plane block (QLPB) and erector spinae plane block (ESPB) are among these regional anesthesia techniques for pain management.
Erector spinae plane block is an emerging block, with low risk and more feasibility, but efficacy hasn't been compared to quadratus lumborum and paravertebral plane blocks altogether in radical cystectomy surgeries.
All these blocks are effective in reducing postoperative pain and the need of analgesia in radical cystectomy surgery; this is a comparative study between the three blocks in this population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESPB group | Active comparator | Procedure: Erector Spinae Plane BlockErector Spinae Plane Block |
| TPVPB group | Active comparator | Procedure: Thoracic Paravertebral Plane BlockThoracic Paravertebral Plane Block |
| QLPB group | Active comparator | Procedure: Quadratus Lumborum Plane BlockQuadratus Lumborum Plane Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) class II - III.
- Adult patients scheduled for radical cystectomy.
Key exclusion criteria (7 listed)
- Patient refusal.
- Uncooperative patients.
- Patients with known allergies to local anesthetics.
- Bleeding disorders or coagulopathy.
- Anatomical abnormality or infection at injection site.
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 |
|---|---|---|
| Erector Spinae Plane BlockAfter skin sterilization, ESP block will be performed at the level of T9. A curvilinear high-frequency ultrasound transducer will be placed sagittal 3 cm lateral to T9 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 30 mL of 0.25% bupivacaine will be injected. Sonographic confirmation of the local anesthetic spread will be seen as an anechoic shadow in the paravertebral spaces from T7 to T12. This procedure will be done on both sides. | Procedure or surgery | ESPB group |
| Thoracic Paravertebral Plane BlockAfter skin sterilization, curvilinear high-frequency ultrasound transducer will be used to visualize the T10 paravertebral space in the paramedian sagittal plane. An injection into the paravertebral space will spread to multiple adjacent dermatomes, so exact identification of a specific level will be not necessary. A 22-gauge spinal needle will be inserted in-plane relative to the ultrasound probe and slowly be directed from lateral to medial until its tip was located at the apex of the paravertebral space and the endpoint for successful block will be anterior displacement of the pleura by injected local anesthetic where a single injection of 30 ml of 0.25% bupivacaine will be injected. This procedure will be done on both sides. | Procedure or surgery | TPVPB group |
| Quadratus Lumborum Plane BlockAfter skin sterilization, curvilinear high-frequency ultrasound transducer will be positioned horizontally in the anterior axillary line halfway between the subcostal margin and iliac crest, to locate the triple abdominal muscle layers, then the probe will be relocated subsequently to the posterior axillary line until the quadratus lumborum muscle could be visualized with its attachment to the lateral edge of the transverse process of the L4 vertebral body. With the psoas major muscle anteriorly, the erector spinae muscle posteriorly and the quadratus lumborum muscle adherent to the apex of the transverse process, this is a well-recognizable pattern of a shamrock with three leaves. A 22-gauge spinal needle will be inserted in-plane relative to the ultrasound probe passing in posterior to anterior direction through the quadratus lumborum to reach the border between it and psoas major, where 30 ml of 0.25% bupivacaine will be injected. This procedure will be done on both sides. | Procedure or surgery | QLPB group |
Primary outcome
Morphine consumption.
Time frame: 24 hours
Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.
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 8 May 2024.
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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.
Moustafa M Zalat, MSc principal investigator
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Nazmy S Michael, MD study director
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo 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 Erector Spinae Plane Block, Thoracic Paravertebral Plane Block and Quadratus Lumborum Plane Block in people with Cancer, Bladder and Surgery, run by Nazmy Edward Seif 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 2 inclusion and 7 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 8 May 2024. 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?
Morphine consumption. (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 8 May 2024.