Modified Radical MastectomyNCT06404918
Preemptive Erector Spinae Plane Block Versus Serratus Anterior Plane Block in MRM
A study testing Erector spinae plane group and Serratus anterior plane group in people with Modified Radical Mastectomy, run by Benha University at 1 site in Egypt.
Trial summary
Modified radical mastectomy (MRM) is one of the most performed surgeries for breast cancer. MRM is associated with significant pain during the immediate postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Modified Radical Mastectomy
- What is being tested?
- Erector spinae plane group and Serratus anterior plane group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jan 2023to 3 Apr 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients
- aged from 18 to 70 years
- with a body mass index ≤ 30 kg/ m2
- American Society of Anesthesiologists (ASA) physical status I-II,
- who were scheduled for MRM for breast cancer
Who cannot join
- history of drug allergy,
- psychiatric illness, substance abuse,
- severe cardiovascular or respiratory disease,
- any pre-existing liver disease, metabolic or neurological syndrome, c
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Preemptive Erector Spinae Plane Block Versus Serratus Anterior Plane Block on Postoperative Analgesia for Patients Undergoing Modified Radical Mastectomy: A Randomized Clinical Trial
Modified radical mastectomy (MRM) is one of the most performed surgeries for breast cancer. MRM is associated with significant pain during the immediate postoperative period.
Read the detailed description
Modified radical mastectomy (MRM) is one of the most performed surgeries for breast cancer. MRM is associated with significant pain during the immediate postoperative period.
Inadequate pain management has both psychological and physiological repercussions.
Various local or regional nerve blocks like thoracic epidural, interscalene brachial plexus, paravertebral, pectoral nerve blocks, and erector spinae plane blocks are performed in MRM to provide analgesia.
Ultrasound-guided Erector spinae plane block (USG-ESPB) is one of the novel and effective regional techniques where local anaesthetic is deposited deep into the erector spinae muscle, blocking the ventral and dorsal rami of multiple spinal nerves, and is technically simple, with fewer hemodynamic side effects and with minimal complications
- Conditions
- Modified Radical Mastectomy
- Being tested
- Erector spinae plane group, Serratus anterior plane group
- Keywords
- Erector Spinae Plane Block, Serratus Anterior Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane groupProcedure or surgery
Also called US ESPB group
The patients were placed in lateral decubitus position with the operation site up. The probe was placed vertically 3 cm lateral to the T5 spinous process, and the transverse process was identified as an oval hyperechoic sonographic structure. The needle was introduced in an in-plane fashion until the tip lay deep in the erector spinae muscle. 0.5 mL of normal saline was injected to confirm the correct needle tip position by visualizing the spread under the erector spinae muscle. A total of 0.4 mL kg-1 of 0.25% bupivacaine was injected. between the erector spinae muscle and transverse process.
Serratus anterior plane groupProcedure or surgery
Also called USAPB group
Serratus anterior plane block was administered to patient in the supine position with ipsilateral arm abducted to 90°. Under aseptic precautions, linear probe was placed over the midclavicular region in the sagittal plane. Ribs were counted inferiorly and laterally until the fifth rib was identified in midaxillary line. Latissimus dorsi, teres major, and serratus anterior muscles were identified overlying the fifth rib. The intended puncture site was infiltrated with 2 mL of 2% lignocaine, and using ultrasound-guided in-plane approach, the needle was introduced in caudal to cranial direction until the tip was placed between the serratus anterior muscle and external intercostal muscle.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane group | Experimental | The patients were placed in lateral decubitus position with the operation site up. The probe was placed vertically 3 cm lateral to the T5 spinous process, and the transverse process was identified as an oval hyperechoic sonographic structure. The needle was introduced in an in-plane fashion until the tip lay deep in the erector spinae muscle. 0.5 mL of normal saline was injected to confirm the correct needle tip position by visualizing the spread under the erector spinae muscle. A total of 0.4 mL kg-1 of 0.25% bupivacaine was injected. between the erector spinae muscle and transverse process. Receives: Procedure: Erector spinae plane group |
| Serratus anterior plane group | Experimental | Serratus anterior plane block was administered to patient in the supine position with ipsilateral arm abducted to 90°. Under aseptic precautions, linear probe was placed over the midclavicular region in the sagittal plane. Ribs were counted inferiorly and laterally until the fifth rib was identified in midaxillary line. Latissimus dorsi, teres major, and serratus anterior muscles were identified overlying the fifth rib. The intended puncture site was infiltrated with 2 mL of 2% lignocaine, and using ultrasound-guided in-plane approach, the needle was introduced in caudal to cranial direction until the tip was placed between the serratus anterior muscle and external intercostal muscle. Receives: Procedure: Serratus anterior plane group |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of the first rescue analgesic dose
The time when the first dose of rescue analgesia was administered at the recovery room,
Measured: 24 hours postoperatively
Secondary outcomes (2)
Heart rate changes
Heart rate (HR) was recorded immediately before induction of anaesthesia, 1
Measured: 15 minutes after performing the block, and then every 30 minutes intraoperatively till the end of surgery, then postoperatively at 1hour and 2 hours, 4hours, 8hours, 12hours, 18hours, 24hours postoperatively.
Mean arterial pressure changes
Mean arterial pressure
Measured: 15 minutes after performing the block, and then every 30 minutes intraoperatively till the end of surgery, then postoperatively at 1hour and 2 hours, 4hours, 8hours, 12hours, 18hours, 24hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start22 Jan 2023
- Primary completion22 Feb 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modified Radical MastectomyStudies of the same condition, open and under way.
- More trials run by Benha 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group I (35 patients): patients received US ESPB and group II (35 patients): patients received USAPB.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy Mousa, Benha University
- Investigators
- Ramy Saleh, MD, Principal investigator, Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404918
- Sponsor's protocol ID
- RC 23-11-2023
- Status last verified
- Apr 2024
- First submitted
- 1 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Preemptive Erector Spinae Plane Block Versus Serratus Anterior Plane Block on Postoperative Analgesia for Patients Undergoing Modified Radical Mastectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06404918
- Acronym / sponsor ID
- RC 23-11-2023
- Conditions
- Modified Radical Mastectomy
- Keywords
- Erector Spinae Plane Block, Serratus Anterior Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 22 Jan 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 8 May 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.
Modified radical mastectomy (MRM) is one of the most performed surgeries for breast cancer. MRM is associated with significant pain during the immediate postoperative period.
Detailed description
Modified radical mastectomy (MRM) is one of the most performed surgeries for breast cancer. MRM is associated with significant pain during the immediate postoperative period.
Inadequate pain management has both psychological and physiological repercussions.
Various local or regional nerve blocks like thoracic epidural, interscalene brachial plexus, paravertebral, pectoral nerve blocks, and erector spinae plane blocks are performed in MRM to provide analgesia.
Ultrasound-guided Erector spinae plane block (USG-ESPB) is one of the novel and effective regional techniques where local anaesthetic is deposited deep into the erector spinae muscle, blocking the ventral and dorsal rami of multiple spinal nerves, and is technically simple, with fewer hemodynamic side effects and with minimal complications
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Group I (35 patients): patients received US ESPB and group II (35 patients): patients received USAPB.
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane group | Experimental | Procedure: Erector spinae plane groupThe patients were placed in lateral decubitus position with the operation site up. The probe was placed vertically 3 cm lateral to the T5 spinous process, and the transverse process was identified as an oval hyperechoic sonographic structure. The needle was introduced in an in-plane fashion until the tip lay deep in the erector spinae muscle. 0.5 mL of normal saline was injected to confirm the correct needle tip position by visualizing the spread under the erector spinae muscle. A total of 0.4 mL kg-1 of 0.25% bupivacaine was injected. between the erector spinae muscle and transverse process. |
| Serratus anterior plane group | Experimental | Procedure: Serratus anterior plane groupSerratus anterior plane block was administered to patient in the supine position with ipsilateral arm abducted to 90°. Under aseptic precautions, linear probe was placed over the midclavicular region in the sagittal plane. Ribs were counted inferiorly and laterally until the fifth rib was identified in midaxillary line. Latissimus dorsi, teres major, and serratus anterior muscles were identified overlying the fifth rib. The intended puncture site was infiltrated with 2 mL of 2% lignocaine, and using ultrasound-guided in-plane approach, the needle was introduced in caudal to cranial direction until the tip was placed between the serratus anterior muscle and external intercostal muscle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- female patients
- aged from 18 to 70 years
- with a body mass index ≤ 30 kg/ m2
- American Society of Anesthesiologists (ASA) physical status I-II,
- who were scheduled for MRM for breast cancer
Key exclusion criteria (4 listed)
- history of drug allergy,
- psychiatric illness, substance abuse,
- severe cardiovascular or respiratory disease,
- any pre-existing liver disease, metabolic or neurological syndrome, c
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 groupAlso: US ESPB groupThe patients were placed in lateral decubitus position with the operation site up. The probe was placed vertically 3 cm lateral to the T5 spinous process, and the transverse process was identified as an oval hyperechoic sonographic structure. The needle was introduced in an in-plane fashion until the tip lay deep in the erector spinae muscle. 0.5 mL of normal saline was injected to confirm the correct needle tip position by visualizing the spread under the erector spinae muscle. A total of 0.4 mL kg-1 of 0.25% bupivacaine was injected. between the erector spinae muscle and transverse process. | Procedure or surgery | Erector spinae plane group |
| Serratus anterior plane groupAlso: USAPB groupSerratus anterior plane block was administered to patient in the supine position with ipsilateral arm abducted to 90°. Under aseptic precautions, linear probe was placed over the midclavicular region in the sagittal plane. Ribs were counted inferiorly and laterally until the fifth rib was identified in midaxillary line. Latissimus dorsi, teres major, and serratus anterior muscles were identified overlying the fifth rib. The intended puncture site was infiltrated with 2 mL of 2% lignocaine, and using ultrasound-guided in-plane approach, the needle was introduced in caudal to cranial direction until the tip was placed between the serratus anterior muscle and external intercostal muscle. | Procedure or surgery | Serratus anterior plane group |
Primary outcome
time of the first rescue analgesic dose
Time frame: 24 hours postoperatively
The time when the first dose of rescue analgesia was administered at the recovery room,
2 secondary outcomes
Heart rate changes
Time frame: 15 minutes after performing the block, and then every 30 minutes intraoperatively till the end of surgery, then postoperatively at 1hour and 2 hours, 4hours, 8hours, 12hours, 18hours, 24hours postoperatively.
Mean arterial pressure changes
Time frame: 15 minutes after performing the block, and then every 30 minutes intraoperatively till the end of surgery, then postoperatively at 1hour and 2 hours, 4hours, 8hours, 12hours, 18hours, 24hours postoperatively.
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 8 May 2024.
- Individual participant dataSharing planned: No
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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.
Ramy Saleh, MD principal investigator
Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
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 group and Serratus anterior plane group in people with Modified Radical Mastectomy, run by Benha 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 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 8 May 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?
time of the first rescue analgesic dose (time frame: 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 8 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.