AnalgesiaNCT05591417
Dexmedetomidine vs Dexamethasone as Adjuvant to Bupivacaine in Bilevel Erector Spinae Plane Block in Breast Surgeries
A study testing Bilevel Erector spinae plane block, Bilateral Erector spinae plane block with dexamethasone and Bilateral Erector spinae plane block with dexmedetomidine in people with Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
High percent of patients experience chronic pain following breast cancer surgeries thus proper perioperative pain control is crucial to lessen the incidence of such pain. Several techniques are adopted to control perioperative pain, these techniques include drugs as opioids and adjuvants as well as regional blocks. 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, Bilateral Erector spinae plane block with dexamethasone and Bilateral Erector spinae plane block with dexmedetomidine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Oct 2022to 30 Sep 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 patients scheduled for Modified Radical Mastectomy MRM
- Physical status ASA II, III.
- Age (18-65) years
- Body mass index (BMI): (20-35) kg/m2.
Who cannot join
- Patient refusal.
- Age <18 years or >65 years.
- BMI <20 kg/m2 and >35 kg/m2.
- Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids, dexamethasone, dexmedetomedine).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Dexmedetomidine and Dexamethasone as Adjuvant to Bupivacaine in Ultrasound-guided Bilevel Erector Spinae Plane Block in Modified Radical Mastectomy
High percent of patients experience chronic pain following breast cancer surgeries thus proper perioperative pain control is crucial to lessen the incidence of such pain. Several techniques are adopted to control perioperative pain, these techniques include drugs as opioids and adjuvants as well as regional blocks. Erector spinae plane block is a regional technique that is used efficiently to control perioperative pain during and following breast cancer surgeries.
Read the detailed description
High percent of patients experience chronic pain following breast cancer surgeries thus proper perioperative pain control is crucial to lessen the incidence of such pain. Several techniques are adopted to control perioperative pain, these techniques include drugs as opioids and adjuvants as well as regional blocks. Erector spinae plane block is a regional technique that is used efficiently to control perioperative pain during and following breast cancer surgeries. Adding adjuvant drugs as dexmedetomidine or dexamethasone can augment the local anesthetic effect for the regional block used.
- Conditions
- Analgesia
- Being tested
- Bilevel Erector spinae plane block, Bilateral Erector spinae plane block with dexamethasone, Bilateral Erector spinae plane block with dexmedetomidine, 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
Also called BileveL ESPB
Patients will receive bilevel erector spinae plane block with bupivacaine
Bilateral Erector spinae plane block with dexamethasoneProcedure or surgery
Also called Bilevel ESPB with dexamethasone
Patients will receive bilevel erector spinae plane block with bupivacaine and dexamethasone
Bilateral Erector spinae plane block with dexmedetomidineProcedure or surgery
Also called Bilevel ESPB with dexmedetomidine
Patients will receive bilevel erector spinae plane block with bupivacaine and dexmedetomidine
Intravenous morphineDrug
Also called Morphine
Intravenous morphine 0.1 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Intravenous morphine | Active comparator | Patients will receive intravenous morphine 0.1 mg/kg Receives: Drug: Intravenous morphine |
| Bilevel erector spinae plane block | Experimental | Patients will receive erector spinae plane block at 2 levels Receives: Procedure: Bilevel Erector spinae plane block |
| Bilevel erector spinae plane block with dexamethasone | Experimental | Patients will receive erector spinae plane block at 2 levels with dexamethasone Receives: Procedure: Bilateral Erector spinae plane block with dexamethasone |
| Bilevel erector spinae plane block with dexmedetomidine | Experimental | Patients will receive erector spinae plane block at 2 levels with dexmedetomidine Receives: Procedure: Bilateral Erector spinae plane block with dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption in the first 24 hours postoperatively.
Assessment of 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 posted24 Oct 2022
- Study start27 Oct 2022
- Primary completion25 Sep 2024
- Study completion30 Sep 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 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, Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591417
- Sponsor's protocol ID
- AP2207-30110
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2022
- Last updated
- 29 Oct 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 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dexmedetomidine and Dexamethasone as Adjuvant to Bupivacaine in Ultrasound-guided Bilevel Erector Spinae Plane Block in Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT05591417
- Acronym / sponsor ID
- AP2207-30110
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 24 Oct 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.
High percent of patients experience chronic pain following breast cancer surgeries thus proper perioperative pain control is crucial to lessen the incidence of such pain. Several techniques are adopted to control perioperative pain, these techniques include drugs as opioids and adjuvants as well as regional blocks. Erector spinae plane block is a regional technique that is used efficiently to control perioperative pain during and following breast cancer surgeries.
Detailed description
High percent of patients experience chronic pain following breast cancer surgeries thus proper perioperative pain control is crucial to lessen the incidence of such pain. Several techniques are adopted to control perioperative pain, these techniques include drugs as opioids and adjuvants as well as regional blocks. Erector spinae plane block is a regional technique that is used efficiently to control perioperative pain during and following breast cancer surgeries. Adding adjuvant drugs as dexmedetomidine or dexamethasone can augment the local anesthetic effect for the regional block used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intravenous morphine | Active comparator | Drug: Intravenous morphinePatients will receive intravenous morphine 0.1 mg/kg |
| Bilevel erector spinae plane block | Experimental | Procedure: Bilevel Erector spinae plane blockPatients will receive erector spinae plane block at 2 levels |
| Bilevel erector spinae plane block with dexamethasone | Experimental | Procedure: Bilateral Erector spinae plane block with dexamethasonePatients will receive erector spinae plane block at 2 levels with dexamethasone |
| Bilevel erector spinae plane block with dexmedetomidine | Experimental | Procedure: Bilateral Erector spinae plane block with dexmedetomidinePatients will receive erector spinae plane block at 2 levels with dexmedetomidine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients scheduled for Modified Radical Mastectomy MRM
- Physical status ASA II, III.
- Age (18-65) years
- Body mass index (BMI): (20-35) kg/m2.
Key exclusion criteria (4 listed)
- Patient refusal.
- Age <18 years or >65 years.
- BMI <20 kg/m2 and >35 kg/m2.
- Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids, dexamethasone, dexmedetomedine).
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 blockAlso: BileveL ESPBPatients will receive bilevel erector spinae plane block with bupivacaine | Procedure or surgery | Bilevel erector spinae plane block |
| Bilateral Erector spinae plane block with dexamethasoneAlso: Bilevel ESPB with dexamethasonePatients will receive bilevel erector spinae plane block with bupivacaine and dexamethasone | Procedure or surgery | Bilevel erector spinae plane block with dexamethasone |
| Bilateral Erector spinae plane block with dexmedetomidineAlso: Bilevel ESPB with dexmedetomidinePatients will receive bilevel erector spinae plane block with bupivacaine and dexmedetomidine | Procedure or surgery | Bilevel erector spinae plane block with dexmedetomidine |
| Intravenous morphineAlso: MorphineIntravenous morphine 0.1 mg/kg | Drug | Intravenous morphine |
Primary outcome
Total morphine consumption in the first 24 hours postoperatively.
Time frame: First 24 hours postoperatively
Assessment of 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 29 Oct 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.
Walaa Y Elsabeeny, MD principal investigator
Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, 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 Bilevel Erector spinae plane block, Bilateral Erector spinae plane block with dexamethasone and Bilateral Erector spinae plane block with dexmedetomidine 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 4 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 29 Oct 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 in the first 24 hours postoperatively. (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 29 Oct 2024.