AnalgesiaNCT05429489
Erector Spinae Plane Block Versus General Anesthesia in Breast Cancer Surgeries
A study testing Bilevel erector spinae plane block, Single level erector spinae plane block and Intravenous morphine in people with Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This study aims at comparing the analgesic efficacy and safety of bilevel erector spinae versus single level versus general anesthesia for breast cancer surgeries Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- Bilevel erector spinae plane block, Single level erector spinae plane block and Intravenous morphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Jun 2022to 10 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Diagnosed with breast cancer
Who cannot join
- Patient refusal
- coagulation defects
- bone metastases
- abnormal kidney and/or liver function tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Bilevel Erector Spinae Plane Block and Single Level Erector Spinae Plane Block Versus General Anesthesia in Breast Cancer Surgeries
This study aims at comparing the analgesic efficacy and safety of bilevel erector spinae versus single level versus general anesthesia for breast cancer surgeries
- Conditions
- Analgesia
- Being tested
- Bilevel erector spinae plane block, Single level erector spinae plane block, Intravenous morphine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilevel erector spinae plane blockProcedure or surgery
Bilevel erector spinae plane block at 3rd and 5th thoracic vertebral levels
Single level erector spinae plane blockProcedure or surgery
Single level erector spinae plane block at 5th thoracic vertebrae
Intravenous morphineDrug
Intravenous morphine 0.1 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Bilevel erector spinae plane block | Experimental | Bilevel erector spinae block at 3rd and 5th thoracic vertebral levels Receives: Procedure: Bilevel erector spinae plane block |
| Single level erector spinae plane block | Experimental | single level erector spinae plane block at 5th thoracic vertebral levels Receives: Procedure: Single level erector spinae plane block |
| Intravenous morphine | Active comparator | Intravenous morphine 0.1 mg/ kg Receives: Drug: Intravenous morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total analgesic requisite
total postoperative morphine consumption
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start27 Jun 2022
- Primary completion27 Dec 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
- Investigators
- Walaa Y Elsabeeny, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429489
- Sponsor's protocol ID
- AP2205-5015
- Status last verified
- Jan 2024
- First submitted
- 17 Jun 2022
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Bilevel Erector Spinae Plane Block and Single Level Erector Spinae Plane Block Versus General Anesthesia in Breast Cancer Surgeries
- ClinicalTrials.gov ID
- NCT05429489
- Acronym / sponsor ID
- AP2205-5015
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 23 Jun 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.
This study aims at comparing the analgesic efficacy and safety of bilevel erector spinae versus single level versus general anesthesia for breast cancer surgeries
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilevel erector spinae plane block | Experimental | Procedure: Bilevel erector spinae plane blockBilevel erector spinae block at 3rd and 5th thoracic vertebral levels |
| Single level erector spinae plane block | Experimental | Procedure: Single level erector spinae plane blocksingle level erector spinae plane block at 5th thoracic vertebral levels |
| Intravenous morphine | Active comparator | Drug: Intravenous morphineIntravenous morphine 0.1 mg/ kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female
- Diagnosed with breast cancer
Key exclusion criteria (4 listed)
- Patient refusal
- coagulation defects
- bone metastases
- abnormal kidney and/or liver function tests
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 |
|---|---|---|
| Bilevel erector spinae plane blockBilevel erector spinae plane block at 3rd and 5th thoracic vertebral levels | Procedure or surgery | Bilevel erector spinae plane block |
| Single level erector spinae plane blockSingle level erector spinae plane block at 5th thoracic vertebrae | Procedure or surgery | Single level erector spinae plane block |
| Intravenous morphineIntravenous morphine 0.1 mg/kg | Drug | Intravenous morphine |
Primary outcome
Total analgesic requisite
Time frame: First 24 hours postoperatively
total postoperative morphine consumption
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 23 Jan 2024.
Related trials for Analgesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
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.
Walaa Y Elsabeeny, MD principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilevel erector spinae plane block, Single level erector spinae plane block and Intravenous morphine in people with Analgesia, run by National Cancer Institute, Egypt 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 4 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 23 Jan 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 analgesic requisite (time frame: First 24 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 23 Jan 2024.