Erector Spinae Plane BlockNCT06422182
Erector Spinae Plane Block in Radical Cystectomy
A study testing Bupivacain 25% (Erector Spinae Plane Block) in people with Erector Spinae Plane Block and Radical Cystectomy, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The aim of this research is to study and compare the efficacy and safety of bilateral single injection erector spinae plane block (ESPB) compared with intravenous patient-controlled analgesia (IV-PCA) in managing postoperative pain after radical cystectomy. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Erector Spinae Plane Block, Radical Cystectomy
- What is being tested?
- Bupivacain 25% (Erector Spinae Plane Block)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2021to 15 Jan 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of the patient between 21 to 65 years.
- Both sexes.
- Body mass index (BMI): 20 - 40 kg/m2.
- American Society of Anesthesiologists (ASA) physical status II-III.
- Elective radical cystectomy.
Who cannot join
- Patient refusal.
- Psychiatric and cognitive disorders.
- Local infection at the site of injection.
- Allergy to study medications.
- Anatomic abnormalities.
- Inability to comprehend or participate in pain scoring system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Erector Spinae Plane Block in Radical Cystectomy: A Randomized Controlled Study
The aim of this research is to study and compare the efficacy and safety of bilateral single injection erector spinae plane block (ESPB) compared with intravenous patient-controlled analgesia (IV-PCA) in managing postoperative pain after radical cystectomy.
Read the detailed description
Radical cystectomy (RC) is one of the most challenging surgical techniques in Urology. Acute postsurgical pain is frequently detrimental in a patient's recovery and quality of life.
Intravenous patient-controlled analgesia (IV-PCA) is one of the most commonly used strategies in clinical practice for controlling postoperative pain. It involves continuous administration of a programmed dose of analgesics, while also allowing patients to receive additional, need-based doses.
One such avenue is the erector spinae plane block (ESPB), a novel analgesic technique first described in 2016 by Forero et al. Although the mechanism of action of the ESPB is unknown, a proposed mechanism is via blockade of the dorsal and ventral rami of thoracic/lumbar spinal nerves. ESPB has been used as analgesia in rib fractures and other thoracic procedures as well as in abdominal surgeries.
- Conditions
- Erector Spinae Plane Block, Radical Cystectomy
- Being tested
- Bupivacain 25% (Erector Spinae Plane Block), Morphine (Intravenous patient-controlled analgesia)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacain 25% (Erector Spinae Plane Block)Drug
Patients received ultrasound guided bilateral single shot erector spinae pane block (ESPB) at Th10 level with 20 mL 0.25% bupivacaine after the end of surgery.
Morphine (Intravenous patient-controlled analgesia)Drug
Patients received intravenous patient-controlled analgesia (IV-PCA) by morphine
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block group | Experimental | Patients received ultrasound guided bilateral single shot erector spinae pane block (ESPB) at Th10 level with 20 mL 0.25% bupivacaine after the end of surgery. Receives: Drug: Bupivacain 25% (Erector Spinae Plane Block) |
| Intravenous patient-controlled analgesia group | Active comparator | Patients received Intravenous patient-controlled analgesia (IV-PCA) by morphine Receives: Drug: Morphine (Intravenous patient-controlled analgesia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Bolus dose of IV morphine (3mg) was provided as a rescue analgesia when the numeric rating scale (NRS) ≥ 4.
Measured: 48 hours postoperatively
Secondary outcomes (3)
The time of first rescue analgesia
Time from end of surgery to first dose of morphine administrated.
Measured: 48 hours postoperatively
Degree of pain
Pain assessment will be done at rest and during coughing or movement by numeric rating scale (NRS) from 0 to 10 where 0 means no pain and 10 being worst pain) at PACU, 2, 4, 8, 12, 16 24, 36 and 48 postoperative.
Measured: 48 hours postoperatively
Incidence of side effects
Side effects such as hypotension, bradycardia, respiratory depression (respiratory rate <10/minute), urinary retention and postoperative nausea and vomiting (PONV) will be recorded and managed.
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start25 Jul 2021
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Plane BlockStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Ezzat Abd El Galil, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422182
- Sponsor's protocol ID
- 2112-301-058
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Erector Spinae Plane Block in Radical Cystectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06422182
- Acronym / sponsor ID
- 2112-301-058
- Conditions
- Erector Spinae Plane Block, Radical Cystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 20 May 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 research is to study and compare the efficacy and safety of bilateral single injection erector spinae plane block (ESPB) compared with intravenous patient-controlled analgesia (IV-PCA) in managing postoperative pain after radical cystectomy.
Detailed description
Radical cystectomy (RC) is one of the most challenging surgical techniques in Urology. Acute postsurgical pain is frequently detrimental in a patient's recovery and quality of life.
Intravenous patient-controlled analgesia (IV-PCA) is one of the most commonly used strategies in clinical practice for controlling postoperative pain. It involves continuous administration of a programmed dose of analgesics, while also allowing patients to receive additional, need-based doses.
One such avenue is the erector spinae plane block (ESPB), a novel analgesic technique first described in 2016 by Forero et al. Although the mechanism of action of the ESPB is unknown, a proposed mechanism is via blockade of the dorsal and ventral rami of thoracic/lumbar spinal nerves. ESPB has been used as analgesia in rib fractures and other thoracic procedures as well as in abdominal surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block group | Experimental | Drug: Bupivacain 25% (Erector Spinae Plane Block)Patients received ultrasound guided bilateral single shot erector spinae pane block (ESPB) at Th10 level with 20 mL 0.25% bupivacaine after the end of surgery. |
| Intravenous patient-controlled analgesia group | Active comparator | Drug: Morphine (Intravenous patient-controlled analgesia)Patients received Intravenous patient-controlled analgesia (IV-PCA) by morphine |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of the patient between 21 to 65 years.
- Both sexes.
- Body mass index (BMI): 20 - 40 kg/m2.
- American Society of Anesthesiologists (ASA) physical status II-III.
- Elective radical cystectomy.
Key exclusion criteria (6 listed)
- Patient refusal.
- Psychiatric and cognitive disorders.
- Local infection at the site of injection.
- Allergy to study medications.
- Anatomic abnormalities.
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 |
|---|---|---|
| Bupivacain 25% (Erector Spinae Plane Block)Patients received ultrasound guided bilateral single shot erector spinae pane block (ESPB) at Th10 level with 20 mL 0.25% bupivacaine after the end of surgery. | Drug | Erector Spinae Plane Block group |
| Morphine (Intravenous patient-controlled analgesia)Patients received intravenous patient-controlled analgesia (IV-PCA) by morphine | Drug | Intravenous patient-controlled analgesia group |
Primary outcome
Total morphine consumption
Time frame: 48 hours postoperatively
Bolus dose of IV morphine (3mg) was provided as a rescue analgesia when the numeric rating scale (NRS) ≥ 4.
3 secondary outcomes
The time of first rescue analgesia
Time frame: 48 hours postoperatively
Degree of pain
Time frame: 48 hours postoperatively
Incidence of side effects
Time frame: 48 hours postoperatively
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 21 May 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacain 25% (Erector Spinae Plane Block) in people with Erector Spinae Plane Block and Radical Cystectomy, run by Kafrelsheikh 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 5 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 21 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?
Total morphine consumption (time frame: 48 hours postoperatively). 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 21 May 2024.