AnaesthesiaNCT06714682
Comparing Post-operative Analgesia After (PECS II) Block and (ESPB) in Modified Radical Mastectomy
A study testing Modified Pectoral Plane block group and Erector spinae plane block group. in people with Anaesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the analgesic efficacies of the modified pectoral plane block (PECS II) and the erector spinae plane block (ESPB) after modified radical mastectomy surgery through assessment of post-operative pain severity by Visual Analogue Score at PACU as a primary outcome and at 2 hours, 4… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Anaesthesia
- What is being tested?
- Modified Pectoral Plane block group and Erector spinae plane block group.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients scheduled for MRM.
- Age eligible ≥ 40 \& ≤ 65 yrs.
- Patients with American Society of Anesthesiologists (ASA) physical status I, II who will be scheduled for Modified Radical Mastectomy surgery.
Who cannot join
- Age < 40 \& > 65 years old.
- Declining to give written informed consent.
- History of allergy to the medications used in the study.
- Contraindication to regional anesthesia [including coagulopathy (platelet count ≤ 80,000, INR ≥ 1.5) and local infection].
- Severe hepatic impairment (INR ≥ 1.5, Bilirubin ≥ 2, Albumin ≤ 2).
- Renal dysfunction [GFR < 50 ml/min calculated by MDRD (Modification of diet in renal disease) equation for GFR estimation (Livio et al., 2008)].
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- Psychiatric disorder.
- Pregnancy.
- Patient with history of thoracic spine surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Modified Pectoral Plane (PECS II) Block Versus Erector Spinae Plane Block (ESPB) for Postoperative Analgesia of Modified Radical Mastectomy
The aim of this study is to compare the analgesic efficacies of the modified pectoral plane block (PECS II) and the erector spinae plane block (ESPB) after modified radical mastectomy surgery through assessment of post-operative pain severity by Visual Analogue Score at PACU as a primary outcome and at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively also by comparing time of first rescue analgesia and cumulative post-operative meperidine consumption in the first 24 hours as secondary outcomes.
Read the detailed description
During MRM , some of the nerves in the chest are affected so most women have some level of pain in the days after the procedure. Severe acute postoperative pain following breast surgery is an independent risk factor in the development of chronic post-mastectomy pain , not only increasing the risk of persistent agony and prolongs hospitalization, it also affects recovery and increases healthcare costs .
Multimodal techniques for pain management have been recommended by the American Society of Anesthesiologists (ASA) for the management of acute postoperative pain . These techniques include oral analgesics as opioids, paracetamol and nonsteroidal anti inflammatory drugs (NSAIDs) , intravenous (IV) and regional analgesia. Inappropriate postoperative analgesia may increase morbidity and mortality .
PECS-II block is an interfascial plane block in which local anesthetic is injected between serratus anterior and pectoralis muscles that blocks the pectoral nerve as well as the long thoracic, intercostobrachial and lateral cutaneous branches of the inter-costal III, IV, V, and VI nerves. PECS-II is a less invasive and easier to be performed alternative to thoracic paravertebral block (TPVB). This block, defined by Blanco et al., provides safe and adequate post-operative analgesia in the anterior chest wall after breast surgery. The most common complications are pneumothorax, vascular puncture, infection, local anesthetic systemic toxicity (LAST), allergy and failed block .
ESPB is a paraspinal fascial plane block in which local anesthetic is injected between the tip of the transverse process of the spine and the anterior fascia of the erector spinae muscles blocking the dorsal and ventral rami of the spinal nerves, as well as the sympathetic chain, resulting in analgesia of chronic thoracic neuropathic pain, breast and upper abdominal surgeries. The block, defined by Forero et al., can cover several spinal nerve levels above and below the injection site as the local anesthetic spreads along the fascial plane, depending on the volume and concentration of the local anesthetic . The main advantages of this technique include the ease of performing it, the analgesic efficacy and the low risk of complications as Pneumothorax, hemi-diaphragmatic paralysis, motor weakness, and neurological findings related to local anesthesia toxicity .
- Conditions
- Anaesthesia
- Being tested
- Modified Pectoral Plane block group, Erector spinae plane block group.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Pectoral Plane block groupProcedure or surgery
Also called PECS II
The patient will lay supine with the ipsilateral arm abducted and externally rotated and the elbow flexed at 90 degrees. The probe will be placed transversely between the clavicle medially and above and the shoulder joint laterally. After identifying the pectoralis major and minor muscles and the plane between them, the probe will be pushed 1-2 cm caudally and medially. In a caudal tilt, within a biconvex space, the artery will be recognised. After that, the block needle will be inserted in an in-plane approach to the artery's location and 10 mL of 0.25% bupivacaine will be administered Then probe will be moved laterally and caudally towards the anterior axillary fold until the serratus muscle appears beneath the pectoralis minor muscle attaching to the underlying ribs. The needle will target the plane between pectoralis minor and serratus muscles at the level of the third rib, followed by negative aspiration into the fascial plane then injection of 10 mL of 0.25 bupivacaine.
Erector spinae plane block group.Procedure or surgery
Also called ESPB
The block will be performed with the patient in a sitting position , The high-frequency linear probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified, the block needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle, 20 mL of 0.25% bupivacaine will be administered for block performance.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Modified Pectoral Plane Block group | Active comparator | first group 10 patients Receives: Procedure: Modified Pectoral Plane block group |
| Erector Spinae Plane Block group | Active comparator | second group 10 patients Receives: Procedure: Erector spinae plane block group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain Severity Assessed by Visual Analogue Scale Immediately Postoperative on Admission to the Post Anesthesia Care Unit.
Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome
Measured: will be evaluated postoperatively on arrival to PACU (zero time)
Secondary outcomes (1)
Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively.
Post-operative pain severity assessed by Visual analogue scale at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable).
Measured: 24 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Jun 2024
- Primary completion1 Nov 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed ibrahim hassan mohamed, Ain Shams University
- Investigators
- Mohamed Ibrahim, MD, Principal investigator, Faculty Of Medicine , Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714682
- Sponsor's protocol ID
- FMASU MS458/2024
- Status last verified
- May 2025
- First submitted
- 28 Nov 2024
- Last updated
- 28 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Modified Pectoral Plane (PECS II) Block Versus Erector Spinae Plane Block (ESPB) for Postoperative Analgesia of Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT06714682
- Acronym / sponsor ID
- FMASU MS458/2024
- Conditions
- Anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Posted 4 May 2025
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 efficacies of the modified pectoral plane block (PECS II) and the erector spinae plane block (ESPB) after modified radical mastectomy surgery through assessment of post-operative pain severity by Visual Analogue Score at PACU as a primary outcome and at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively also by comparing time of first rescue analgesia and cumulative post-operative meperidine consumption in the first 24 hours as secondary outcomes.
Detailed description
During MRM , some of the nerves in the chest are affected so most women have some level of pain in the days after the procedure. Severe acute postoperative pain following breast surgery is an independent risk factor in the development of chronic post-mastectomy pain , not only increasing the risk of persistent agony and prolongs hospitalization, it also affects recovery and increases healthcare costs .
Multimodal techniques for pain management have been recommended by the American Society of Anesthesiologists (ASA) for the management of acute postoperative pain . These techniques include oral analgesics as opioids, paracetamol and nonsteroidal anti inflammatory drugs (NSAIDs) , intravenous (IV) and regional analgesia. Inappropriate postoperative analgesia may increase morbidity and mortality .
PECS-II block is an interfascial plane block in which local anesthetic is injected between serratus anterior and pectoralis muscles that blocks the pectoral nerve as well as the long thoracic, intercostobrachial and lateral cutaneous branches of the inter-costal III, IV, V, and VI nerves. PECS-II is a less invasive and easier to be performed alternative to thoracic paravertebral block (TPVB). This block, defined by Blanco et al., provides safe and adequate post-operative analgesia in the anterior chest wall after breast surgery. The most common complications are pneumothorax, vascular puncture, infection, local anesthetic systemic toxicity (LAST), allergy and failed block .
ESPB is a paraspinal fascial plane block in which local anesthetic is injected between the tip of the transverse process of the spine and the anterior fascia of the erector spinae muscles blocking the dorsal and ventral rami of the spinal nerves, as well as the sympathetic chain, resulting in analgesia of chronic thoracic neuropathic pain, breast and upper abdominal surgeries. The block, defined by Forero et al., can cover several spinal nerve levels above and below the injection site as the local anesthetic spreads along the fascial plane, depending on the volume and concentration of the local anesthetic . The main advantages of this technique include the ease of performing it, the analgesic efficacy and the low risk of complications as Pneumothorax, hemi-diaphragmatic paralysis, motor weakness, and neurological findings related to local anesthesia toxicity .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Modified Pectoral Plane Block group | Active comparator | Procedure: Modified Pectoral Plane block groupfirst group 10 patients |
| Erector Spinae Plane Block group | Active comparator | Procedure: Erector spinae plane block group.second group 10 patients |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients scheduled for MRM.
- Age eligible ≥ 40 \& ≤ 65 yrs.
- Patients with American Society of Anesthesiologists (ASA) physical status I, II who will be scheduled for Modified Radical Mastectomy surgery.
Key exclusion criteria (9 listed)
- Age < 40 \& > 65 years old.
- Declining to give written informed consent.
- History of allergy to the medications used in the study.
- Contraindication to regional anesthesia [including coagulopathy (platelet count ≤ 80,000, INR ≥ 1.5) and local infection].
- Severe hepatic impairment (INR ≥ 1.5, Bilirubin ≥ 2, Albumin ≤ 2).
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 |
|---|---|---|
| Modified Pectoral Plane block groupAlso: PECS IIThe patient will lay supine with the ipsilateral arm abducted and externally rotated and the elbow flexed at 90 degrees. The probe will be placed transversely between the clavicle medially and above and the shoulder joint laterally. After identifying the pectoralis major and minor muscles and the plane between them, the probe will be pushed 1-2 cm caudally and medially. In a caudal tilt, within a biconvex space, the artery will be recognised. After that, the block needle will be inserted in an in-plane approach to the artery's location and 10 mL of 0.25% bupivacaine will be administered Then probe will be moved laterally and caudally towards the anterior axillary fold until the serratus muscle appears beneath the pectoralis minor muscle attaching to the underlying ribs. The needle will target the plane between pectoralis minor and serratus muscles at the level of the third rib, followed by negative aspiration into the fascial plane then injection of 10 mL of 0.25 bupivacaine. | Procedure or surgery | Ultrasound-Guided Modified Pectoral Plane Block group |
| Erector spinae plane block group.Also: ESPBThe block will be performed with the patient in a sitting position , The high-frequency linear probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified, the block needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle, 20 mL of 0.25% bupivacaine will be administered for block performance. | Procedure or surgery | Erector Spinae Plane Block group |
Primary outcome
Post-operative Pain Severity Assessed by Visual Analogue Scale Immediately Postoperative on Admission to the Post Anesthesia Care Unit.
Time frame: will be evaluated postoperatively on arrival to PACU (zero time)
Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome
1 secondary outcome
Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively.
Time frame: 24 hours post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Mohamed Ibrahim, MD principal investigator
Faculty Of Medicine , Ain Shams 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 Modified Pectoral Plane block group and Erector spinae plane block group. in people with Anaesthesia, run by Ain Shams 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 3 inclusion and 9 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 28 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?
Yes. Results are posted in the registry (first posted 4 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-operative Pain Severity Assessed by Visual Analogue Scale Immediately Postoperative on Admission to the Post Anesthesia Care Unit. (time frame: will be evaluated postoperatively on arrival to PACU (zero time)). 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 28 May 2025.