Erector Spinae Plane BlockNCT06498739
Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy
A study testing Erector spinae plane block(15 ml bupivacaine 0.5%) and Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline) in people with Erector Spinae Plane Block and Modified Radical Mastectomy, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Erector Spinae Plane Block, Modified Radical Mastectomy
- What is being tested?
- Erector spinae plane block(15 ml bupivacaine 0.5%) and Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline)
- 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
- 1 Mar 2024to 1 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18 to 60 years.
- Genders eligible for study: female sex.
- American Society of Anesthesiologists (ASA) I-II.
- Undergoing modified radical mastectomy.
- Body mass index (BMI) from 18.5 to 30 kg.
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.
- 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
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.
Read the detailed description
Breast cancer is the most common malignancy among females with incidence of about 2.1 million women each year. Modified Radical Mastectomy (MRM) is one of the main surgical treatments of breast cancer.
Pain can be severe enough to cause long-term disabilities and interfere with sleep and performance of daily activities . Multiple regional techniques have been developed in recent years for postoperative analgesia of breast surgery inkling erector spinae plane block (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 block (ESPB) 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.
- Being tested
- Erector spinae plane block(15 ml bupivacaine 0.5%), Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane block(15 ml bupivacaine 0.5%)Drug
Patients will preoperatively receive high concentration-low volume ultrasound 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 patient).
Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline)Drug
Patients will preoperatively receive low concentration-high volume ultrasound 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.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane block (high concentration-low volume) | Other | Patients will preoperatively receive high concentration-low volume ultrasound 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 patient). Receives: Drug: Erector spinae plane block(15 ml bupivacaine 0.5%) |
| Erector Spinae Plane block (low concentration-high volume) | Other | Patients will preoperatively receive low concentration-high volume ultrasound 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. Receives: Drug: Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Rescue analgesia will be provided in the form of intravenous morphine 3 mg boluses if the patient indicates visual analogue scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed.
Visual Analogue Scale (VAS) (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 24 hours postoperative
Secondary outcomes (2)
Time 1st rescue analgesia
All patients will receive paracetamol 1gm and intravenous ketorolac 30mg will be provided as a part of multimodal analgesia. Rescue analgesia will be provided in the form of intravenous morphine 3 mg boluses if the patient indicates visual analogue scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed.
Visual Analogue Scale (VAS) (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 24 hours postoperative
Pain score
Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").it will be assess at 0 , 4, 8, 12, 16, 20 and 24 hours postoperatively.
Measured: 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 posted12 Jul 2024
- Study start1 Mar 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 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 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmina Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498739
- Sponsor's protocol ID
- MS-520-2022
- Status last verified
- May 2025
- First submitted
- 13 Dec 2023
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- 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 2025. 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
- NCT06498739
- Acronym / sponsor ID
- MS-520-2022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 12 Jul 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.
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.
Detailed description
Breast cancer is the most common malignancy among females with incidence of about 2.1 million women each year. Modified Radical Mastectomy (MRM) is one of the main surgical treatments of breast cancer.
Pain can be severe enough to cause long-term disabilities and interfere with sleep and performance of daily activities . Multiple regional techniques have been developed in recent years for postoperative analgesia of breast surgery inkling erector spinae plane block (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 block (ESPB) 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane block (high concentration-low volume) | Other | Drug: Erector spinae plane block(15 ml bupivacaine 0.5%)Patients will preoperatively receive high concentration-low volume ultrasound 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 patient). |
| Erector Spinae Plane block (low concentration-high volume) | Other | Drug: Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline)Patients will preoperatively receive low concentration-high volume ultrasound 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age from 18 to 60 years.
- Genders eligible for study: female sex.
- American Society of Anesthesiologists (ASA) I-II.
- Undergoing modified radical mastectomy.
- Body mass index (BMI) from 18.5 to 30 kg.
Key exclusion criteria (7 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 |
|---|---|---|
| Erector spinae plane block(15 ml bupivacaine 0.5%)Patients will preoperatively receive high concentration-low volume ultrasound 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 patient). | Drug | Erector Spinae Plane block (high concentration-low volume) |
| Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline)Patients will preoperatively receive low concentration-high volume ultrasound 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 | Erector Spinae Plane block (low concentration-high volume) |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperative
Rescue analgesia will be provided in the form of intravenous morphine 3 mg boluses if the patient indicates visual analogue scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed. Visual Analogue Scale (VAS) (0 represents "no pain" while 10 represents "the worst pain imaginable").
2 secondary outcomes
Time 1st rescue analgesia
Time frame: 24 hours postoperative
Pain score
Time frame: 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 21 May 2025.
- 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 Erector spinae plane block(15 ml bupivacaine 0.5%) and Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline) in people with Erector Spinae Plane Block and Modified Radical Mastectomy, 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 7 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 2025. 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: 24 hours postoperative). 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 2025.