UltrasoundNCT06884852
Ultrasound-guided Multilevel Erectorspinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome for Breast Cancer Patients
A study testing Erector spinae plane block (ESPB) and Thoracic epidural block in people with Ultrasound and Multilevel Erector Spinae Plane Block, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
The aim of this study is to compare the analgesic efficacy of multilevel erector spinae plane block (ESPB) vs thoracic epidural in modified radical mastectomy (MRM) regarding duration of analgesia, postoperative opioid consumption, effect on intraoperative fentanyl consumption, postoperative numerical pain rating… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Ultrasound, Multilevel Erector Spinae Plane Block, Thoracic Epidural Analgesia
- What is being tested?
- Erector spinae plane block (ESPB) and Thoracic epidural block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 patients age ≥ 18 years and ≤ 65 Years.
- Type of surgery; Modified Radical Mastectomy (MRM)
- Physical status ASA II, III.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
Who cannot join
- Patient refusal.
- Allergy or a contraindication to the drug used in the study, e.g. local anesthetics, opioids.
- History of psychological disorders.
- History of chronic pain.
- Contraindication to regional anesthesia e.g. sepsis, peripheral neuropathies and coagulopathy.
- Advanced chronic renal disease, which is defined as a chronic kidney disease (CKD) in which there is a severe reduction in glomerular filtration rate (GFR < 30 ml/min) and includes stages 4 and 5 of the CKD classification.
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- Decompensated cirrhosis, which is defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage.
- Severe heart disease which is defined as NYHA class iii (moderate symptoms with less than normal activity, marked limitation of function status) or NYHA class IV (severe symptoms with features of heart failure with minimal activity or at rest and severe limitation of functional status)
- Severe lung disease which includes oxygen saturation of blood less than 92%, RR more than 20, FEV1/FVC ratio less than 60%.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute
Cairo, 11796
Ahmed El Abdelaal, Master, 00201097900275, drahmedsayeh9915@gmail.com
Ghada G Elsayed, MD
About this study
The aim of this study is to compare the analgesic efficacy of multilevel erector spinae plane block (ESPB) vs thoracic epidural in modified radical mastectomy (MRM) regarding duration of analgesia, postoperative opioid consumption, effect on intraoperative fentanyl consumption, postoperative numerical pain rating scale and quality of life for the next 6 months.
Read the detailed description
Breast cancer is the most common malignancy among females. Modified Radical Mastectomy (MRM) is the principal surgical treatment for breast cancer. The standard mode of anesthesia is general anesthesia, in addition to regional blocks for effective postoperative pain control.
Pain is usually managed by narcotics, which have many side effects, including prolonged sedation, increasing incidence of pain recurrence, respiratory depression, nausea \& vomiting and paralytic ileus. All requiring close monitoring and in some occasions Intensive Care Unit (ICU) admission. Thoracic epidural and paravertebral blocks are the gold standard techniques. However, both techniques may lead to some serious complications including spinal cord injury, pneumothorax, incompatibility with pre-existing anticoagulation or antiplatelet therapy and hemodynamic instability.
Recently, multiple regional techniques have been used for postoperative thoracic pain control, including that caused by modified radical mastectomy. Interfascial plane blocks are currently the hot topic in management of postoperative pain. One of these blocks is erector spinae plane block (ESPB). It is an interfacial Para spinal plane block that is simple, safe, effective and associated with fewer complications in comparison to the gold standard techniques.
- Conditions
- Ultrasound, Multilevel Erector Spinae Plane Block, Thoracic Epidural Analgesia, Post Mastectomy, Pain Syndrome, Breast Cancer Patients
- Being tested
- Erector spinae plane block (ESPB), Thoracic epidural block
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane block (ESPB)Drug
Also called Bupivacaine 0.25%
Erector spinae plane block (ESPB) using multilevel injections of bupivacaine 0.25%.
We will inject 15ml at the level of T2 and 15ml at the level of T5.
Thoracic epidural blockDrug
Also called Bupivacaine 0.25%
Thoracic epidural block at level of T5 -T6 using 10 ml of bupivacaine 0.25% as a bolus followed by 5 ml bupivacaine 0.25% every 1-2 hours depending on the duration of surgery and the response of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block (ESPB) | Experimental | Erector spinae plane block (ESPB) using multilevel injections of bupivacaine 0.25%.
We injected 15ml at the level of T2 and 15ml at the level of T5. Receives: Drug: Erector spinae plane block (ESPB) |
| Thoracic epidural block | Experimental | Thoracic epidural block at level of T5 -T6 using 10 ml of bupivacaine 0.25% as a bolus followed by 5 ml bupivacaine 0.25% every 1-2 hours depending on the duration of surgery and the response of the patient. Receives: Drug: Thoracic epidural block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average duration of analgesia
The average duration of analgesia will be recorded from the end of surgery till the first dose of morphine administrated.
Measured: 24 hours postoperatively
Secondary outcomes (10)
The total amount of morphine
Patient will be discharged to the ward then rescue analgesia will be given in the form of IV morphine 3 mg boluses if the patient reported Numeric Pain Rating Scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups.
Measured: 24 hours postoperatively
Incidence of postmastectomy pain syndrome
Incidence of postmastectomy pain syndrome at 1, 3, and 6 months postoperatively will be recorded.
Measured: 6 months postoperatively
The total amount of fentanyl
Fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of the baseline levels.
Measured: Intraoperatively
Heart rate (HR)
Heart rate will be noted at 4, 8, 12, 16, 20, and 24 hours postoperatively
Measured: 24 hours Postoperatively
Mean arterial blood pressure (MAP)
Mean arterial blood pressure will be noted at 4, 8, 12, 16, 20, and 24 hours postoperatively
Measured: 24 hours Postoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be recorded (at rest and during movement) at 0, 4, 8, 12, 16, 20, and 24 hours postoperatively.
Measured: 24 hours Postoperatively
Incidence of Postoperative nausea and vomiting (PONV).
Postoperative nausea and vomiting (PONV) will be rated on a four-point verbal scale; (none =no nausea, mild = nausea but no vomiting, moderate= vomiting one attack, severe =vomiting > one attack). 0.1 mg/kg of IV ondansetron will be given to patients with moderate or severe postoperative nausea and vomiting.Nausea and vomiting Scores using a four-point verbal scale; on arrival to post-anesthesia care unit (PACU), scoring at 0, 4, 8,12,16,20 and 24 hours postoperatively.
Measured: 24 hours Postoperatively
Complications related to the block
Complications related to the block such as local anesthetics, systemic toxicity, and vascular injury will be recorded
Measured: 6 months postoperatively
Morphine-related complications
Patient will be discharged to the ward then rescue analgesia will be given in the form of IV morphine 3 mg boluses if the patient reported Numeric Pain Rating Scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. Morphine-related complications such as respiratory depression, urine retention, or pruritis will be recorded.
Measured: 24 hours Postoperatively
Patient's satisfaction
Patient's satisfaction: the patient will be classified in this group as satisfied or not.
Measured: 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 posted19 Mar 2025
- Study start20 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ahmed elsayeh, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884852
- Sponsor's protocol ID
- AP2405-201-046-193
- Status last verified
- May 2025
- First submitted
- 13 Mar 2025
- Last updated
- 21 May 2025
- Results posted
- 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
- Ultrasound-guided Multilevel Erectorspinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome for Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06884852
- Acronym / sponsor ID
- AP2405-201-046-193
- Conditions
- Ultrasound, Multilevel Erector Spinae Plane Block, Thoracic Epidural Analgesia, Post Mastectomy, Pain Syndrome, Breast Cancer Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 19 Mar 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.
The aim of this study is to compare the analgesic efficacy of multilevel erector spinae plane block (ESPB) vs thoracic epidural in modified radical mastectomy (MRM) regarding duration of analgesia, postoperative opioid consumption, effect on intraoperative fentanyl consumption, postoperative numerical pain rating scale and quality of life for the next 6 months.
Detailed description
Breast cancer is the most common malignancy among females. Modified Radical Mastectomy (MRM) is the principal surgical treatment for breast cancer. The standard mode of anesthesia is general anesthesia, in addition to regional blocks for effective postoperative pain control.
Pain is usually managed by narcotics, which have many side effects, including prolonged sedation, increasing incidence of pain recurrence, respiratory depression, nausea \& vomiting and paralytic ileus. All requiring close monitoring and in some occasions Intensive Care Unit (ICU) admission. Thoracic epidural and paravertebral blocks are the gold standard techniques. However, both techniques may lead to some serious complications including spinal cord injury, pneumothorax, incompatibility with pre-existing anticoagulation or antiplatelet therapy and hemodynamic instability.
Recently, multiple regional techniques have been used for postoperative thoracic pain control, including that caused by modified radical mastectomy. Interfascial plane blocks are currently the hot topic in management of postoperative pain. One of these blocks is erector spinae plane block (ESPB). It is an interfacial Para spinal plane block that is simple, safe, effective and associated with fewer complications in comparison to the gold standard techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block (ESPB) | Experimental | Drug: Erector spinae plane block (ESPB)Erector spinae plane block (ESPB) using multilevel injections of bupivacaine 0.25%. We injected 15ml at the level of T2 and 15ml at the level of T5. |
| Thoracic epidural block | Experimental | Drug: Thoracic epidural blockThoracic epidural block at level of T5 -T6 using 10 ml of bupivacaine 0.25% as a bolus followed by 5 ml bupivacaine 0.25% every 1-2 hours depending on the duration of surgery and the response of the patient. |
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 patients age ≥ 18 years and ≤ 65 Years.
- Type of surgery; Modified Radical Mastectomy (MRM)
- Physical status ASA II, III.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
Key exclusion criteria (10 listed)
- Patient refusal.
- Allergy or a contraindication to the drug used in the study, e.g. local anesthetics, opioids.
- History of psychological disorders.
- History of chronic pain.
- Contraindication to regional anesthesia e.g. sepsis, peripheral neuropathies and coagulopathy.
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 (ESPB)Also: Bupivacaine 0.25%Erector spinae plane block (ESPB) using multilevel injections of bupivacaine 0.25%. We will inject 15ml at the level of T2 and 15ml at the level of T5. | Drug | Erector spinae plane block (ESPB) |
| Thoracic epidural blockAlso: Bupivacaine 0.25%Thoracic epidural block at level of T5 -T6 using 10 ml of bupivacaine 0.25% as a bolus followed by 5 ml bupivacaine 0.25% every 1-2 hours depending on the duration of surgery and the response of the patient. | Drug | Thoracic epidural block |
Primary outcome
The average duration of analgesia
Time frame: 24 hours postoperatively
The average duration of analgesia will be recorded from the end of surgery till the first dose of morphine administrated.
10 secondary outcomes
The total amount of morphine
Time frame: 24 hours postoperatively
Incidence of postmastectomy pain syndrome
Time frame: 6 months postoperatively
The total amount of fentanyl
Time frame: Intraoperatively
Heart rate (HR)
Time frame: 24 hours Postoperatively
Mean arterial blood pressure (MAP)
Time frame: 24 hours Postoperatively
Degree of pain
Time frame: 24 hours Postoperatively
Incidence of Postoperative nausea and vomiting (PONV).
Time frame: 24 hours Postoperatively
Complications related to the block
Time frame: 6 months postoperatively
Morphine-related complications
Time frame: 24 hours Postoperatively
Patient's satisfaction
Time frame: 24 hours Postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
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 (ESPB) and Thoracic epidural block in people with Ultrasound and Multilevel Erector Spinae Plane Block, run by National Cancer Institute, Egypt 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 10 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed El Abdelaal, Master (00201097900275, drahmedsayeh9915@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average duration of analgesia (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 21 May 2025.