AnalgesiaNCT04796363
US Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation
A study testing Erector Spinae Plane Block with Bubivacaine and Standard General Anaesthesia in people with Analgesia and Breast Cancer, run by Alexandria University at 1 site in Egypt.
Trial summary
Prospective interventional study Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Analgesia, Breast Cancer
- What is being tested?
- Erector Spinae Plane Block with Bubivacaine and Standard General Anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2020to 21 Jan 2022
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Patient refusal.
- Allergy or contraindication to any of the studied medications or anaesthetic agents.
- Chronic opioid analgesic use.
- Pregnancy.
- Morbid obesity (BMI ≥ 40 kg/m2).
- Scoliosis or any vertebral anomalies or previous spinal surgeries.
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- Infection at the site of injection or any other contraindication for regional anaesthesia.
- Duration of surgery more than 90 minutes.
- Renal impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation
Prospective interventional study
Read the detailed description
The aim of the present study is to evaluate the effect of US guided unilateral ESPB using different volumes of local anaesthetics on analgesic efficacy, dermatomal spread and immunomodulation in breast cancer surgery.
The primary outcome is the analgesic efficacy of the different local anaesthetic volumes of ESPB.
The secondary outcomes are the dermatomal dye spread and sensory coverage, immunomodulation and complications in breast cancer surgery.
Immunomodulation will be assessed by measuring Natural killer cells cytotoxicity.
- Conditions
- Analgesia, Breast Cancer
- Being tested
- Erector Spinae Plane Block with Bubivacaine, Standard General Anaesthesia
- Keywords
- Erector spinae plane block, Ultrasound guided, Breast cancer surgery, Natural killer cells, Analgesia, spread
- Medical subject headings
- Agnosia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane Block with BubivacaineProcedure or surgery
Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery
Standard General AnaesthesiaProcedure or surgery
Standard General Anaesthesia without ESPB
| Study group | Role | What they receive |
|---|---|---|
| ESPB Bubivacaine 0.25% | Experimental | 20 patients will receive US-guided deep ESPB block before induction of general anaesthesia using 20 ml bupivacaine 0.25 % and 5 ml of radiocontrast dye (Omnipaque) at the level of T4. Receives: Procedure: Erector Spinae Plane Block with Bubivacaine |
| ESPB Bubivacaine 0.125% | Active comparator | 20 patients will receive US-guided deep ESPB block before induction of general anaesthesia using 40 ml bupivacaine 0.125 % and 5 ml of radiocontrast dye (Omnipaque) at the level of T4. Receives: Procedure: Erector Spinae Plane Block with Bubivacaine |
| No ESPB | Placebo comparator | 20 patients will undergo standard general anaesthesia as a control group and postoperative analgesia with intravenous morphine patient controlled analgesia (PCA) and rescue analgesia if required. Receives: Procedure: Standard General Anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic efficacy of ESPB
Analgesic efficacy of Erector Spinae plabe block by measuring visual analogue scale which ranges from 0 to 10. 0 indicates no pain and 10 indicates maximum imaginable pain
Measured: Up to 24 postoperative hours
Secondary outcomes (2)
Spread of the injected dye in Erector Spinae plane
5 ml of radio-contrast dye will be injected in Erector Spinae plane with different dose of Bupivacaine at the level of 4th thoracic vertebra then spread of the dye will be assessed by CT scan (for example dye spread to first thoracic vertebra level cranially and 9th thoracic vertebra caudally).
3 D reconstruction of the image will be done then Craniocaudal spread of the contrast and spread to Paravertebral space, epidural space or rami of the spinal nerves will be assessed and recorded.
Measured: Patients will be imaged 15 minutes after the block and before induction of general anaesthesia and surgery.
Dermatomal sensory coverage of ESPB
will be assessed by hyposthesia to cold sensation. Field of sensory block from T1 to T6 will be assessed bilaterally every 3 minutes for 15 minutes after deep ESPB using a piece of cotton soaked in iced water. The adequacy of sensory block T1-T6 will be determined before induction of general anaesthesia.
Measured: Assessment will be done bilaterally every 3 minutes for 15 minutes after ESPB.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start25 Nov 2020
- Primary completion11 Jan 2022
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Mohamed Rabah Abdella, Alexandria University
- Investigators
- Emad Eldin Abd El Monem Arida, Professor, Study chair, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796363
- Sponsor's protocol ID
- Medical Research Institute
- Status last verified
- Apr 2022
- First submitted
- 24 Nov 2020
- Last updated
- 11 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Abdella AMMR, Arida EEAEM, Megahed NA, El-Amrawy WZ, Mohamed WMA. Analgesia and spread of erector spinae plane block in breast cancer surgeries: a randomized controlled trial. BMC Anesthesiol. 2022 Oct 17;22(1):321. doi: 10.1186/s12871-022-01860-w.
PubMed 36253729
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation
- ClinicalTrials.gov ID
- NCT04796363
- Acronym / sponsor ID
- Medical Research Institute
- Conditions
- Analgesia, Breast Cancer
- Keywords
- Erector spinae plane block, Ultrasound guided, Breast cancer surgery, Natural killer cells, Analgesia, spread
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 12 Mar 2021 (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.
Prospective interventional study
Detailed description
The aim of the present study is to evaluate the effect of US guided unilateral ESPB using different volumes of local anaesthetics on analgesic efficacy, dermatomal spread and immunomodulation in breast cancer surgery.
The primary outcome is the analgesic efficacy of the different local anaesthetic volumes of ESPB.
The secondary outcomes are the dermatomal dye spread and sensory coverage, immunomodulation and complications in breast cancer surgery.
Immunomodulation will be assessed by measuring Natural killer cells cytotoxicity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESPB Bubivacaine 0.25% | Experimental | Procedure: Erector Spinae Plane Block with Bubivacaine20 patients will receive US-guided deep ESPB block before induction of general anaesthesia using 20 ml bupivacaine 0.25 % and 5 ml of radiocontrast dye (Omnipaque) at the level of T4. |
| ESPB Bubivacaine 0.125% | Active comparator | Procedure: Erector Spinae Plane Block with Bubivacaine20 patients will receive US-guided deep ESPB block before induction of general anaesthesia using 40 ml bupivacaine 0.125 % and 5 ml of radiocontrast dye (Omnipaque) at the level of T4. |
| No ESPB | Placebo comparator | Procedure: Standard General Anaesthesia20 patients will undergo standard general anaesthesia as a control group and postoperative analgesia with intravenous morphine patient controlled analgesia (PCA) and rescue analgesia if required. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Patient refusal.
- Allergy or contraindication to any of the studied medications or anaesthetic agents.
- Chronic opioid analgesic use.
- Pregnancy.
- Morbid obesity (BMI ≥ 40 kg/m2).
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 Block with BubivacaineErector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery | Procedure or surgery | ESPB Bubivacaine 0.125%, ESPB Bubivacaine 0.25% |
| Standard General AnaesthesiaStandard General Anaesthesia without ESPB | Procedure or surgery | No ESPB |
Primary outcome
Analgesic efficacy of ESPB
Time frame: Up to 24 postoperative hours
Analgesic efficacy of Erector Spinae plabe block by measuring visual analogue scale which ranges from 0 to 10. 0 indicates no pain and 10 indicates maximum imaginable pain
2 secondary outcomes
Spread of the injected dye in Erector Spinae plane
Time frame: Patients will be imaged 15 minutes after the block and before induction of general anaesthesia and surgery.
Dermatomal sensory coverage of ESPB
Time frame: Assessment will be done bilaterally every 3 minutes for 15 minutes after ESPB.
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 11 Apr 2022.
- Derived from this study: PubMed 36253729Abdella AMMR, Arida EEAEM, Megahed NA, El-Amrawy WZ, Mohamed WMA. Analgesia and spread of erector spinae plane block in breast cancer surgeries: a randomized controlled trial. BMC Anesthesiol. 2022 Oct 17;22(1):321. doi: 10.1186/s12871-022-01860-w.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Emad Eldin Abd El Monem Arida, Professor study chair
University of Alexandria
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 with Bubivacaine and Standard General Anaesthesia in people with Analgesia and Breast Cancer, run by Alexandria 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 0 inclusion and 9 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 11 Apr 2022. 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. Some participants in this study may receive a placebo. 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?
Analgesic efficacy of ESPB (time frame: Up to 24 postoperative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04796363, which also lists 1 linked publication.
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 11 Apr 2022.