Breast Cancer PatientsRISS-ESPBNCT07041762
Rhomboid Intercostal Block With Sub-Serratus Plane Block Versus Erector Spinae Block
A study testing Rhomboid Intercostal Block with Sub-Serratus Plane Block and Erector Spinae Plane Block in people with Breast Cancer Patients, run by Cairo University at 1 site in Egypt.
Trial summary
This study compares two nerve block techniques-Rhomboid Intercostal with Sub-Serratus Plane Block versus Erector Spinae Plane Block-for pain relief after breast cancer surgery. It aims to determine which method provides better postoperative pain control, reduces opioid use, and improves recovery in patients undergoing… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer Patients
- What is being tested?
- Rhomboid Intercostal Block with Sub-Serratus Plane Block and Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 8 Aug 2026
- 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 breast cancer patients undergoing Modified Radical Mastectomy (MRM)
- ASA physical status II or III
- Age between 18 and 65 years
- Body Mass Index (BMI) > 20 kg/m² and < 35 kg/m²
Who cannot join
- Patient refusal
- ASA physical status IV
- Age <18 years or >65 years
- BMI < 20 kg/m² or > 35 kg/m²
- Known allergy or contraindication to local anesthetics or opioids
- History of psychological disorders or chronic pain
- Contraindications to regional anesthesia (e.g., coagulopathy, local infection, peripheral neuropathy)
- Severe respiratory, cardiac, hepatic, or renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Rhomboid Intercostal Block With Sub-Serratus Plane Block Versus Erector Spinae Block in Breast Cancer Surgery
This study compares two nerve block techniques-Rhomboid Intercostal with Sub-Serratus Plane Block versus Erector Spinae Plane Block-for pain relief after breast cancer surgery. It aims to determine which method provides better postoperative pain control, reduces opioid use, and improves recovery in patients undergoing modified radical mastectomy at the National Cancer Institute, Cairo University.
Read the detailed description
This randomized controlled trial aims to evaluate the analgesic efficacy of two ultrasound-guided regional anesthesia techniques-Rhomboid Intercostal Block with Sub-Serratus Plane Block (RIB + SSP) and Erector Spinae Plane Block (ESB)-in patients undergoing Modified Radical Mastectomy (MRM) for breast cancer. Eighty female patients aged 18-65 years with ASA physical status II or III will be enrolled and randomly assigned to receive either RIB + SSP or ESB prior to surgery. Both blocks will be performed under ultrasound guidance 30-45 minutes before induction of general anesthesia.
The primary outcomes are postoperative pain scores measured using the Visual Analog Scale (VAS) and total opioid consumption in the first 24 hours after surgery. Secondary outcomes include intraoperative and postoperative hemodynamic parameters, time to first analgesic request, total intraoperative opioid use, recovery time, patient satisfaction, and incidence of adverse effects such as nausea and vomiting.
The study will be conducted at the National Cancer Institute - Cairo University from June 2025 to June 2026. Ethical approval will be obtained, and written informed consent will be collected. This study aims to identify the more effective and safer regional technique to improve postoperative recovery and reduce opioid dependence in breast cancer patients.
- Conditions
- Breast Cancer Patients
- Being tested
- Rhomboid Intercostal Block with Sub-Serratus Plane Block, Erector Spinae Plane Block
- Keywords
- erector spinae block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhomboid Intercostal Block with Sub-Serratus Plane BlockProcedure or surgery
Ultrasound-guided regional anesthesia combining two injections:
Rhomboid Intercostal Block (15 mL of 0.25% bupivacaine injected between rhomboid major and intercostal space)
Sub-Serratus Plane Block (15 mL of 0.25% bupivacaine injected between serratus anterior and ribs).
Both performed 30-45 minutes before Modified Radical Mastectomy under general anesthesia.
Erector Spinae Plane BlockProcedure or surgery
Ultrasound-guided regional block with 30 mL of 0.25% bupivacaine injected into the paraspinal plane at the T4-T5 level, between the erector spinae muscle and the transverse processes.
Performed 30-45 minutes prior to general anesthesia for Modified Radical Mastectomy.
| Study group | Role | What they receive |
|---|---|---|
| Rhomboid Intercostal Block with Sub-Serratus Plane Block | Experimental | Participants in this group will receive ultrasound-guided Rhomboid Intercostal Block (15 mL of 0.25% bupivacaine between rhomboid major and intercostal space) followed by Sub-Serratus Plane Block (15 mL of 0.25% bupivacaine between serratus anterior and ribs) 30-45 minutes before general anesthesia for Modified Radical Mastectomy. Receives: Procedure: Rhomboid Intercostal Block with Sub-Serratus Plane Block |
| Erector Spinae Plane Block | Active comparator | Participants in this group will receive an ultrasound-guided Erector Spinae Plane Block with 30 mL of 0.25% bupivacaine injected into the paraspinal plane at the T4-T5 level, 30-45 minutes prior to general anesthesia for Modified Radical Mastectomy. Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Scores
Postoperative pain will be assessed using the Visual Analog Scale (VAS) both at rest (static) and during movement (dynamic). Assessments will be conducted at 2, 6, 12, and 24 hours following surgery. The VAS is a 10-centimeter scale, where 0 indicates "no pain" and 10 indicates the "worst imaginable pain." Unit of Measure: VAS score (0-10)
Measured: First 24 hours postoperatively
Secondary outcomes (1)
Total Opioid Consumption
The total amount of opioid analgesics administered within the first 24 postoperative hours will be recorded for each patient. All opioid dosages will be converted to intravenous morphine equivalents for standardization.
Unit of Measure: Milligrams of intravenous morphine equivalents (mg)
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 posted27 Jun 2025
- Study start1 Jun 2025
- Primary completion8 Aug 2026
- Study completion8 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer PatientsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- observer-blinded
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Mahmoud Abed, Cairo University
- Investigators
- Sayed Mahmoud M Abed, MD, Principal investigator, National Cancer Institute - Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041762
- Sponsor's protocol ID
- NCI-CAIRO-RISS-ESPB-2025
- Acronym
- RISS-ESPB
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared due to institutional policies regarding data confidentiality and privacy. Additionally, there is no established infrastructure for secure data sharing or monitoring of secondary data use at this time.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Rhomboid Intercostal Block With Sub-Serratus Plane Block Versus Erector Spinae Block in Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT07041762
- Acronym / sponsor ID
- RISS-ESPB / NCI-CAIRO-RISS-ESPB-2025
- Conditions
- Breast Cancer Patients
- Keywords
- erector spinae block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 8 Aug 2026 (actual)
- Study completion
- 8 Aug 2026 (actual)
- First posted
- 27 Jun 2025 (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.
This study compares two nerve block techniques-Rhomboid Intercostal with Sub-Serratus Plane Block versus Erector Spinae Plane Block-for pain relief after breast cancer surgery. It aims to determine which method provides better postoperative pain control, reduces opioid use, and improves recovery in patients undergoing modified radical mastectomy at the National Cancer Institute, Cairo University.
Detailed description
This randomized controlled trial aims to evaluate the analgesic efficacy of two ultrasound-guided regional anesthesia techniques-Rhomboid Intercostal Block with Sub-Serratus Plane Block (RIB + SSP) and Erector Spinae Plane Block (ESB)-in patients undergoing Modified Radical Mastectomy (MRM) for breast cancer. Eighty female patients aged 18-65 years with ASA physical status II or III will be enrolled and randomly assigned to receive either RIB + SSP or ESB prior to surgery. Both blocks will be performed under ultrasound guidance 30-45 minutes before induction of general anesthesia.
The primary outcomes are postoperative pain scores measured using the Visual Analog Scale (VAS) and total opioid consumption in the first 24 hours after surgery. Secondary outcomes include intraoperative and postoperative hemodynamic parameters, time to first analgesic request, total intraoperative opioid use, recovery time, patient satisfaction, and incidence of adverse effects such as nausea and vomiting.
The study will be conducted at the National Cancer Institute - Cairo University from June 2025 to June 2026. Ethical approval will be obtained, and written informed consent will be collected. This study aims to identify the more effective and safer regional technique to improve postoperative recovery and reduce opioid dependence in breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- observer-blinded
| Arm | Type | Receives |
|---|---|---|
| Rhomboid Intercostal Block with Sub-Serratus Plane Block | Experimental | Procedure: Rhomboid Intercostal Block with Sub-Serratus Plane BlockParticipants in this group will receive ultrasound-guided Rhomboid Intercostal Block (15 mL of 0.25% bupivacaine between rhomboid major and intercostal space) followed by Sub-Serratus Plane Block (15 mL of 0.25% bupivacaine between serratus anterior and ribs) 30-45 minutes before general anesthesia for Modified Radical Mastectomy. |
| Erector Spinae Plane Block | Active comparator | Procedure: Erector Spinae Plane BlockParticipants in this group will receive an ultrasound-guided Erector Spinae Plane Block with 30 mL of 0.25% bupivacaine injected into the paraspinal plane at the T4-T5 level, 30-45 minutes prior to general anesthesia for Modified Radical Mastectomy. |
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 breast cancer patients undergoing Modified Radical Mastectomy (MRM)
- ASA physical status II or III
- Age between 18 and 65 years
- Body Mass Index (BMI) > 20 kg/m² and < 35 kg/m²
Key exclusion criteria (8 listed)
- Patient refusal
- ASA physical status IV
- Age <18 years or >65 years
- BMI < 20 kg/m² or > 35 kg/m²
- Known allergy or contraindication to local anesthetics or opioids
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 |
|---|---|---|
| Rhomboid Intercostal Block with Sub-Serratus Plane BlockUltrasound-guided regional anesthesia combining two injections: Rhomboid Intercostal Block (15 mL of 0.25% bupivacaine injected between rhomboid major and intercostal space) Sub-Serratus Plane Block (15 mL of 0.25% bupivacaine injected between serratus anterior and ribs). Both performed 30-45 minutes before Modified Radical Mastectomy under general anesthesia. | Procedure or surgery | Rhomboid Intercostal Block with Sub-Serratus Plane Block |
| Erector Spinae Plane BlockUltrasound-guided regional block with 30 mL of 0.25% bupivacaine injected into the paraspinal plane at the T4-T5 level, between the erector spinae muscle and the transverse processes. Performed 30-45 minutes prior to general anesthesia for Modified Radical Mastectomy. | Procedure or surgery | Erector Spinae Plane Block |
Primary outcome
Postoperative Pain Scores
Time frame: First 24 hours postoperatively
Postoperative pain will be assessed using the Visual Analog Scale (VAS) both at rest (static) and during movement (dynamic). Assessments will be conducted at 2, 6, 12, and 24 hours following surgery. The VAS is a 10-centimeter scale, where 0 indicates "no pain" and 10 indicates the "worst imaginable pain." Unit of Measure: VAS score (0-10)
1 secondary outcome
Total Opioid Consumption
Time frame: First 24 hours 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 25 Aug 2026.
- Rhomboid intercostal block combined with sub-serratus plane block versus rhomboid intercostal block for postoperative analgesia after video-assisted thoracoscopic surgery: a prospective randomized-controlled trialLink provided by the sponsor.
- Rhomboid Intercostal and Subserratus Plane Block: A Cadaveric and Clinical EvaluationLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared due to institutional policies regarding data confidentiality and privacy. Additionally, there is no established infrastructure for secure data sharing or monitoring of secondary data use at this time.
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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.
Sayed Mahmoud M Abed, MD principal investigator
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 Rhomboid Intercostal Block with Sub-Serratus Plane Block and Erector Spinae Plane Block in people with Breast Cancer Patients, 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 4 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 25 Aug 2026. 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?
Postoperative Pain Scores (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 25 Aug 2026.