UltrasoundNCT06947642
Ultrasound-guided Pectoral Nerve Blocks, Thoracic Erector Spinae Plane Block and Serratus Anterior Plane Block for Breast Surgery
A study testing Pectoral nerve block (PECS), Erector spinae plane block (ESP) and Serratus anterior plane block (SAP) in people with Ultrasound and Pectoral Nerve Blocks, run by Tanta University at 1 site in Egypt.
Trial summary
The study will compare ultrasound-guided Pectoral nerve block, Erector Spinae Plane block, and Serratus anterior plane block for pain management following elective breast surgeries Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Ultrasound, Pectoral Nerve Blocks, Thoracic Erector Spinae Plane Block
- What is being tested?
- Pectoral nerve block (PECS), Erector spinae plane block (ESP) and Serratus anterior plane block (SAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2025to 30 Sep 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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 21 to 65 years old female, American Society of Anesthesiologists (ASA) physical status I or II, who will undergo breast surgeries under general anesthesia.
Who cannot join
- Patient refusal to participate in research.
- Body Mass Index (BMI) ≥35 kg/m2.
- Sensitivity to the intervention drugs.
- Coagulation abnormalities.
- Psychiatric disorder and communication difficulties.
- Chronic neurological disease.
- Any skin infection at the needle puncture site.
- Chest wall deformity
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
Tanta University
Tanta, El-Gharbia, 31527
Rehab S Taha, Master, 00201000507975, rehabsalah2017@gmail.com
Ashraf E Alzftawy, MD
About this study
Official title: Comparison Between Ultrasound-guided Pectoral Nerve Blocks, Thoracic Erector Spinae Plane Block and Serratus Anterior Plane Block for Breast Surgery: A Prospective Randomized Study
The study will compare ultrasound-guided Pectoral nerve block, Erector Spinae Plane block, and Serratus anterior plane block for pain management following elective breast surgeries
Read the detailed description
Adequate acute postoperative pain control is important for patients undergoing breast surgery because the pain may be severe and longlasting. Surgical incision at the breast and axillary areas is associated with significant pain, with high incidence of acute pain progressing to chronic pain in 25% to 60% of patients. Post-mastectomy pain managed with opioids often lead to side effects of nausea and vomiting.
Regional anesthetic techniques are used in the current management of pain associated with breast surgeries .They attenuate surgical stress response , intraoperative consumption of opioid, prevent central sensitization and diminish postoperative pain.
The efficacy of fascial plane blocks like pectoral nerve block (PECS), serratus anterior plane block (SAP), and erector spinae plane block (ESP) has been proven in previous studies. These blocks require deposition of local anesthetic in an inter-fascial plane through which peripheral nerves travel.
The Pectoral nerve block relies upon the deposition the local anesthetic at the inter-fascial planes among the pectoralis major, minor, and serratus anterior muscles: it blocks the pectoral, the intercostobrachial, the intercostals III and VI, and the long thoracic nerves.
Erector Spinae Plane block is another interfacial plane block. It involves deposition of local anesthetic between erector spinae muscle and transverse process of T5 vertebrae and targets both dorsal and ventral rami of thoracic spinal nerves.
Serratus anterior plane block involves the injection of local anesthetic in 1 of the 2 fascial planes, superficial and deep to serratus anterior muscle at the level of the fifth rib in midaxillary line. The SAP block targets the lateral cutaneous branches of the thoracic intercostal nerves. The deep SAP block was found to have similar analgesic efficacy and technically easier and safer to perform as compared to the superficial SAP block.
- Conditions
- Ultrasound, Pectoral Nerve Blocks, Thoracic Erector Spinae Plane Block, Serratus Anterior Plane Block, Breast Surgery
- Being tested
- Pectoral nerve block (PECS), Erector spinae plane block (ESP), Serratus anterior plane block (SAP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectoral nerve block (PECS)Drug
Also called Bupivacaine 0.25
Patients will receive pectoral nerve block (PECS).
Erector spinae plane block (ESP)Drug
Also called Bupivacaine 0.25
Patients will receive erector spinae plane block (ESP).
Serratus anterior plane block (SAP)Drug
Also called Bupivacaine 0.25
Patients will receive serratus anterior plane block (SAP).
| Study group | Role | What they receive |
|---|---|---|
| Pectoral nerve block (PECS) | Experimental | Patients will receive pectoral nerve block (PECS). Receives: Drug: Pectoral nerve block (PECS) |
| Erector spinae plane block (ESP) | Experimental | Patients will receive erector spinae plane block (ESP). Receives: Drug: Erector spinae plane block (ESP) |
| Serratus anterior plane block (SAP) | Experimental | Patients will receive serratus anterior plane block (SAP). Receives: Drug: Serratus anterior plane block (SAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Rescue analgesia of morphine will be given as 3 mg bolus if the visual analogue scale (VAS) ≥ 4 to be repeated after 30 min if pain persists until the VAS< 4.
Measured: 24 hours postoperatively
Secondary outcomes (7)
Time to the 1st rescue analgesia
Time to 1st request for the rescue of analgesia (time from the end of surgery till first dose of morphine administrated) will be recorded.
Measured: 24 hours postoperatively
Intraoperative fentanyl consumption
Intraoperative fentanyl consumption will be recorded.Additional fentanyl bolus dosages of 0.5 µg/kg IV will be administered if mean arterial blood pressure and heart rate elevated more than 20% of the baseline (after exclusion of other causes).
Measured: Intraoperatively
Pain degree
Each patient will be instructed about postoperative pain assessment with the visual analogue scale (VAS) (20), from 0 to 10 (0 represents "no pain" while 10 represents "the worst pain imaginable").Rescue analgesia of morphine will be given as 3 mg bolus if the VAS ≥ 4 to be repeated after 30 min if pain persists until the VAS< 4. VAS will be assessed at 30min, 2, 6,12 and 24 h postoperatively
Measured: 24 hours postoperatively
Mean arterial blood pressure
Intraoperative hemodynamic parameters: Mean arterial blood pressure (MAP) will be recorded at baseline, after performing of block, and every 15 min till the end of surgery.
Measured: Till the end of surgery (Up to 24hours)
Heart rate
Intraoperative hemodynamic parameters: Heart rate (HR) will be recorded at baseline, after performing of block, and every 15 min till the end of surgery.
Measured: Till the end of surgery (Up to 24hours)
Patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Measured: 24 hours Postoperatively
Adverse effects
bradycardia, hypotension, nausea, vomiting, respiratory depression, hematoma at the site of injection, local anesthetic toxicity will be recorded.
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 posted27 Apr 2025
- Study start30 Apr 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 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.
- More trials run by Tanta 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Salah El-Din Taha, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947642
- Sponsor's protocol ID
- 36265MD276/9/24
- Status last verified
- May 2025
- First submitted
- 20 Apr 2025
- Last updated
- 20 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 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound-guided Pectoral Nerve Blocks, Thoracic Erector Spinae Plane Block and Serratus Anterior Plane Block for Breast Surgery: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06947642
- Acronym / sponsor ID
- 36265MD276/9/24
- Conditions
- Ultrasound, Pectoral Nerve Blocks, Thoracic Erector Spinae Plane Block, Serratus Anterior Plane Block, Breast Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 27 Apr 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 study will compare ultrasound-guided Pectoral nerve block, Erector Spinae Plane block, and Serratus anterior plane block for pain management following elective breast surgeries
Detailed description
Adequate acute postoperative pain control is important for patients undergoing breast surgery because the pain may be severe and longlasting. Surgical incision at the breast and axillary areas is associated with significant pain, with high incidence of acute pain progressing to chronic pain in 25% to 60% of patients. Post-mastectomy pain managed with opioids often lead to side effects of nausea and vomiting.
Regional anesthetic techniques are used in the current management of pain associated with breast surgeries .They attenuate surgical stress response , intraoperative consumption of opioid, prevent central sensitization and diminish postoperative pain.
The efficacy of fascial plane blocks like pectoral nerve block (PECS), serratus anterior plane block (SAP), and erector spinae plane block (ESP) has been proven in previous studies. These blocks require deposition of local anesthetic in an inter-fascial plane through which peripheral nerves travel.
The Pectoral nerve block relies upon the deposition the local anesthetic at the inter-fascial planes among the pectoralis major, minor, and serratus anterior muscles: it blocks the pectoral, the intercostobrachial, the intercostals III and VI, and the long thoracic nerves.
Erector Spinae Plane block is another interfacial plane block. It involves deposition of local anesthetic between erector spinae muscle and transverse process of T5 vertebrae and targets both dorsal and ventral rami of thoracic spinal nerves.
Serratus anterior plane block involves the injection of local anesthetic in 1 of the 2 fascial planes, superficial and deep to serratus anterior muscle at the level of the fifth rib in midaxillary line. The SAP block targets the lateral cutaneous branches of the thoracic intercostal nerves. The deep SAP block was found to have similar analgesic efficacy and technically easier and safer to perform as compared to the superficial SAP block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pectoral nerve block (PECS) | Experimental | Drug: Pectoral nerve block (PECS)Patients will receive pectoral nerve block (PECS). |
| Erector spinae plane block (ESP) | Experimental | Drug: Erector spinae plane block (ESP)Patients will receive erector spinae plane block (ESP). |
| Serratus anterior plane block (SAP) | Experimental | Drug: Serratus anterior plane block (SAP)Patients will receive serratus anterior plane block (SAP). |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age from 21 to 65 years old female, American Society of Anesthesiologists (ASA) physical status I or II, who will undergo breast surgeries under general anesthesia.
Key exclusion criteria (8 listed)
- Patient refusal to participate in research.
- Body Mass Index (BMI) ≥35 kg/m2.
- Sensitivity to the intervention drugs.
- Coagulation abnormalities.
- Psychiatric disorder and communication difficulties.
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 |
|---|---|---|
| Pectoral nerve block (PECS)Also: Bupivacaine 0.25Patients will receive pectoral nerve block (PECS). | Drug | Pectoral nerve block (PECS) |
| Erector spinae plane block (ESP)Also: Bupivacaine 0.25Patients will receive erector spinae plane block (ESP). | Drug | Erector spinae plane block (ESP) |
| Serratus anterior plane block (SAP)Also: Bupivacaine 0.25Patients will receive serratus anterior plane block (SAP). | Drug | Serratus anterior plane block (SAP) |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
Rescue analgesia of morphine will be given as 3 mg bolus if the visual analogue scale (VAS) ≥ 4 to be repeated after 30 min if pain persists until the VAS< 4.
7 secondary outcomes
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Intraoperative fentanyl consumption
Time frame: Intraoperatively
Pain degree
Time frame: 24 hours postoperatively
Mean arterial blood pressure
Time frame: Till the end of surgery (Up to 24hours)
Heart rate
Time frame: Till the end of surgery (Up to 24hours)
Patient satisfaction
Time frame: 24 hours Postoperatively
Adverse effects
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 20 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 Pectoral nerve block (PECS), Erector spinae plane block (ESP) and Serratus anterior plane block (SAP) in people with Ultrasound and Pectoral Nerve Blocks, run by Tanta 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 1 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: looking for participants now, as of the sponsor's last update on 20 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 Rehab S Taha, Master (00201000507975, rehabsalah2017@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (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 20 May 2025.