Comparing of 2 Different Volumes in ESPB in Patients Undergoing MRMPhase 2/3NCT05813158
Comparing the Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy
A Phase 2/3 study testing Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block) and Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block) in people with Comparing of 2 Different Volumes in ESPB in Patients Undergoing MRM, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to compare and evaluate the analgesic effects of ultrasound-guided Erector Spinae Plane block using low volumes and high concentrations versus high volumes and low concentrations in patients undergoing MRM. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Comparing of 2 Different Volumes in ESPB in Patients Undergoing MRM
- What is being tested?
- Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block) and Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Sep 2022to 23 Dec 2022
- Phase
- Phase 2/3
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age starting from 18 to 60 years.
- Genders eligible for study: female sex.
- ASA II-III.
- Patients undergoing modified radical mastectomy.
- Body mass index (BMI) from 18.5 to 30 kg/m2.
Who cannot join
- Patient refusal
- Known allergy to local anesthetics
- Bleeding disorders; platelets count <50,000, prothrombin concentration <60% or any coagulopathy disorder.
- Use of any anti-coagulants
- Inability to provide informed consent
- ASA IV
- Neurological disorders
- Patient with psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy A Randomized Comparative Study
The aim of this study is to compare and evaluate the analgesic effects of ultrasound-guided Erector Spinae Plane block using low volumes and high concentrations versus high volumes and low concentrations in patients undergoing MRM.
Read the detailed description
Multiple regional techniques have been developed in recent years for postoperative analgesia of breast surgery including ESPB aiming to be effective and associated with less complications when compared to the gold standard techniques (thoracic epidural analgesia or paravertebral block)..
Ultrasound guided erector spinae plane (ESPB) block was described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain, it has been used as a regional anesthetic technique for breast surgery based on case reports and case series. It is a paraspinal fascial plane block that involves injection of local anesthetic deep in the erector spinae muscle and superficial to the tips of the thoracic transverse processes. The site of injection is distant from the pleura, major blood vessels, and spinal cord; hence, performing the ESPB has relatively few contraindications. The injected local anesthetic drug blocks the ventral and dorsal rami of spinal nerves on the paravertebral area .
Multiple studies have reported improved efficiency of interfascial blocks by increasing the volume of injection promoting better spread of local anesthesia. According to the authors best knowledge there is no studies comparing different volumes and concentration in ESPB in patients undergoing MRM This study aims to see the effect of fixing the drug mass of anaesthetic given in both groups, while altering the concentration of the anesthetic and total volume administered. One group will receive a lower concentration and higher volume, while the other will receive a higher concentration and lower volume.
- Being tested
- Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block), Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block)Drug
Also called Erector Spinae Plane Block with high volume-low concentration bupivacaine 0.25%
Patients will preoperatively receive low concentration-high volume ultasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room ) one syringe of 30ml bupivacaine 0.25% {15 ml bupivacaine 0.5% and 15ml normal saline} for each patient
Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block)Drug
Also called Erector Spinae Plane Block with low volume-high concentration bupivacaine 0.25%
Patients will preoperatively receive high concentration-low volume ultasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room (one syringe of 15 ml bupivacaine 0.5% {15 ml bupivacaine 0.5% } for each patien).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Patients will preoperatively receive low concentration-high volume U/S ESP block, and then the patient will be transferred to the operating room one syringe of 30ml bupivacaine 0.25% {15 ml bupivacaine 0.5% and 15ml normal saline}, for each patient. Receives: Drug: Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block) |
| Group 2 | Active comparator | Patients will preoperatively receive high concentration-low volume U/S ESP block block, and then the patient will be transferred to the operating room one syringe of 15 ml bupivacaine 0.5% {15 ml bupivacaine 0.5% }, for each patien). Receives: Drug: Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of morphine needed postoperatively
Total dose of morphine needed postoperatively
Measured: Through Study Completion Up to 1 Day
Secondary outcomes (6)
Time to first rescue analgesia, starting after extubation
Time to first rescue analgesia, starting after extubation
Measured: Through Study Completion over the first 24 hours postoperative
Duration of surgery
Duration of surgery
Measured: Through Study Completion 24 hours postoperative
Blood loss,
Blood loss,
Measured: Through Study Completion,an average of 1day
Total dose of fentanyl required intraoperative (including induction dose)
Total dose of fentanyl required intraoperative (including induction dose)
Measured: Through study completion,an average of 1day
Pain score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery
Pain score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery
Measured: through study completion,an average of 1day
Need for blood transfusion
Need for blood transfusion
Measured: Through Study Completion over the first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start9 Sep 2022
- Primary completion16 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparing of 2 Different Volumes in ESPB in Patients Undergoing MRMStudies of the same condition, open and under way.
- More trials run by Cairo 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We hypothesize that high volume low concentration ultrasound-guided Erector Spinae Plane block is going to be more effective than low volume high concentration in patients undergoing MRM. Many authors advocate increasing the volume of injection in fascial plane blocks to allow better spread of local anesthetic according to multiple studies
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Yasmina sayed Abdrabo Ismael, Norhan Abdelaleem Ali, Ahmed Shaker Ragab
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
- Investigators
- Ahmed Abdalla Mohamed, M.D, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813158
- Sponsor's protocol ID
- N-44-2022/MSc
- Status last verified
- Apr 2023
- First submitted
- 18 Nov 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Till Study Ending
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT05813158
- Acronym / sponsor ID
- N-44-2022/MSc
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Yasmina sayed Abdrabo Ismael, Norhan Abdelaleem Ali, Ahmed Shaker Ragab
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 14 Apr 2023 (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 study is to compare and evaluate the analgesic effects of ultrasound-guided Erector Spinae Plane block using low volumes and high concentrations versus high volumes and low concentrations in patients undergoing MRM.
Detailed description
Multiple regional techniques have been developed in recent years for postoperative analgesia of breast surgery including ESPB aiming to be effective and associated with less complications when compared to the gold standard techniques (thoracic epidural analgesia or paravertebral block)..
Ultrasound guided erector spinae plane (ESPB) block was described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain, it has been used as a regional anesthetic technique for breast surgery based on case reports and case series. It is a paraspinal fascial plane block that involves injection of local anesthetic deep in the erector spinae muscle and superficial to the tips of the thoracic transverse processes. The site of injection is distant from the pleura, major blood vessels, and spinal cord; hence, performing the ESPB has relatively few contraindications. The injected local anesthetic drug blocks the ventral and dorsal rami of spinal nerves on the paravertebral area .
Multiple studies have reported improved efficiency of interfascial blocks by increasing the volume of injection promoting better spread of local anesthesia. According to the authors best knowledge there is no studies comparing different volumes and concentration in ESPB in patients undergoing MRM This study aims to see the effect of fixing the drug mass of anaesthetic given in both groups, while altering the concentration of the anesthetic and total volume administered. One group will receive a lower concentration and higher volume, while the other will receive a higher concentration and lower volume.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- We hypothesize that high volume low concentration ultrasound-guided Erector Spinae Plane block is going to be more effective than low volume high concentration in patients undergoing MRM. Many authors advocate increasing the volume of injection in fascial plane blocks to allow better spread of local anesthetic according to multiple studies
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block)Patients will preoperatively receive low concentration-high volume U/S ESP block, and then the patient will be transferred to the operating room one syringe of 30ml bupivacaine 0.25% {15 ml bupivacaine 0.5% and 15ml normal saline}, for each patient. |
| Group 2 | Active comparator | Drug: Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block)Patients will preoperatively receive high concentration-low volume U/S ESP block block, and then the patient will be transferred to the operating room one syringe of 15 ml bupivacaine 0.5% {15 ml bupivacaine 0.5% }, for each patien). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age starting from 18 to 60 years.
- Genders eligible for study: female sex.
- ASA II-III.
- Patients undergoing modified radical mastectomy.
- Body mass index (BMI) from 18.5 to 30 kg/m2.
Key exclusion criteria (8 listed)
- Patient refusal
- Known allergy to local anesthetics
- Bleeding disorders; platelets count <50,000, prothrombin concentration <60% or any coagulopathy disorder.
- Use of any anti-coagulants
- Inability to provide informed consent
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 |
|---|---|---|
| Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block)Also: Erector Spinae Plane Block with high volume-low concentration bupivacaine 0.25%Patients will preoperatively receive low concentration-high volume ultasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room ) one syringe of 30ml bupivacaine 0.25% {15 ml bupivacaine 0.5% and 15ml normal saline} for each patient | Drug | Group 1 |
| Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block)Also: Erector Spinae Plane Block with low volume-high concentration bupivacaine 0.25%Patients will preoperatively receive high concentration-low volume ultasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room (one syringe of 15 ml bupivacaine 0.5% {15 ml bupivacaine 0.5% } for each patien). | Drug | Group 2 |
Primary outcome
Total dose of morphine needed postoperatively
Time frame: Through Study Completion Up to 1 Day
Total dose of morphine needed postoperatively
6 secondary outcomes
Time to first rescue analgesia, starting after extubation
Time frame: Through Study Completion over the first 24 hours postoperative
Duration of surgery
Time frame: Through Study Completion 24 hours postoperative
Blood loss,
Time frame: Through Study Completion,an average of 1day
Total dose of fentanyl required intraoperative (including induction dose)
Time frame: Through study completion,an average of 1day
Pain score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery
Time frame: through study completion,an average of 1day
Need for blood transfusion
Time frame: Through Study Completion over the first 24 hours postoperative
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 3 May 2023.
- Individual participant dataSharing planned: Undecided. Till Study Ending
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.
Ahmed Abdalla Mohamed, M.D principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block) and Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block) in people with Comparing of 2 Different Volumes in ESPB in Patients Undergoing MRM, run by Cairo 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 8 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 3 May 2023. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 dose of morphine needed postoperatively (time frame: Through Study Completion Up to 1 Day). 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 3 May 2023.