Breast CancerNCT07807605
Ultrasound Guided Serratus Anterior Plane Block Versus Ultrasound Guided Thoracic Epidural Analgesia
A study testing Bupivacaine 0.25% Injectable Solution in people with Breast Cancer, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Regional/local analgesic techniques are an important component of a multimodal analgesic strategy, with the aim of reducing opioid requirements and opioid-related adverse events. This change parallels quality improvement initiatives and the Enhanced Recover after Surgery. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bupivacaine 0.25% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2023to 10 Jun 2023
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients of the American Society of Anesthesiology physical status (І and ІІ) Female patients.
- Female patients diagnosed with breast malignancy
- Patients with Body weight: patients with body mass index less than 35.
Who cannot join
- Uncooperative patient, those with any contraindication for spinal or epidural anesthesia (systemic coagulopathy-local infection)
- Patients with body mass index >35
- Patients with chronic obstructive pulmonary disease
- Patients with anatomic abnormalities
- Patients with allergy to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Serratus Anterior Plane Block Versus Ultrasound Guided Thoracic Epidural Analgesia for Conservative Breast Surgery: A Comparative Study
Regional/local analgesic techniques are an important component of a multimodal analgesic strategy, with the aim of reducing opioid requirements and opioid-related adverse events. This change parallels quality improvement initiatives and the Enhanced Recover after Surgery.
Breast conserving surgery with radiation therapy is today standard therapy for low grade breast cancer. It is safe and preferred therapeutic procedure in all early detected breast cancers ,because it provide the same level of overall survival rates as seen in patients treated with mastectomy ,have been found by several prospective and randomized studies and number of clinical trials .
Read the detailed description
Acute post-surgical pain leads to delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay.
It is also an important factor leading to the development of chronic persistent post-operative pain in almost half of the patients. Post-operative pain, stress and use of morphine have been elucidated as factors responsible for increased risk of metastasis.
Hence, an effective perioperative pain management of patients undergoing breast surgery is essential. Regional blocks have been considered as one of the modalities for effective perioperative pain control. They have an opioid-sparing effect, and allow early mobilisation and early discharge from hospital.
Ultrasound-guided muscle plane blocks have changed the practice of regional anesthesia for breast surgeries. Different variations of Pecs block have been described with an aim to provide anesthesia and analgesia of the hemi thorax.
Recently described serratus anterior plane (SAP) block was designed to target primarily the thoracic intercostal nerves, providing complete analgesia to the lateral part of the thorax. Compared with Pecs-II, the needle is placed more caudally and posteriorly in SAP block and local anesthetic (LA) is deposited either superficial or deep to the serratus anterior muscle.
Serratus Anterior Plane (SAP) block has been described recently as injection of local Anesthetic (LA) in mid axillary line at the level of the 5th rib either superficial or deep to the serratus anterior (SA) muscle. The intention is to block the thoracic intercostal nerves to provide complete analgesia of the lateral part of the chest.
There are some clinical reports validating its use in breast surgeries. Although serratus anterior plane (SAP) block affects the long thoracic nerve of bell supplying serratus anterior (SA) but there is no mention of blocking the thoracodorsal nerve supplying latissmus dorsi (LD).The thoracodorsal nerve is the sole nerve that supplies latissmus dorsi (LD) and forms a plexus between serratus anterior (SA)and latissmus dorsi (LD).
On the other hand, regarding thoracic epidural analgesia, the results from MRI studies indicate that the spinal cord lies anteriorly within its thecal sac in the thoracic curve and the following measures were found: 5.19 mm in T2, 7.75 mm in T5 and 5.88 mm in T10, this let us say, sufficient distance to permit the careful advancement of a needle (accidentally or intentionally) without reaching the cord and administer anesthetic for a segmental spinal anesthesia. This anatomical explanation was proposed for the absence of spinal cord injury during an accidental perforation during attempted thoracic epidural.
- Conditions
- Breast Cancer
- Being tested
- Bupivacaine 0.25% Injectable Solution
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25% Injectable SolutionDrug
Also called fentanyl
to compare and evaluate safety, efficacy, benefits and complications of thoracic epidural analgesia and serratus anterior plane block in patients undergoing Conservative breast surgery under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Serratus anterior plane block Group | Active comparator | About 35 female patients diagnosed with breast malignancy subjected to Breast Conservative Surgery under general anesthesia by Ultrasound guided serratus anterior plane block anesthesia Receives: Drug: Bupivacaine 0.25% Injectable Solution |
| Thoracic epidural analgesia Group | Active comparator | About 35 female patients diagnosed with breast malignancy subjected to Breast Conservative Surgery under general anesthesia by ultrasound guided Thoracic Epidural Analgesia Receives: Drug: Bupivacaine 0.25% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Pain
the duration of effective analgesia from the block till the first analgesic dose is required.the severity of postoperative pain as assessed by the visual analogue scale ((0 = no pain, 10 = most imaginable pain) at 1, 4, 8, 12, and 24 hours after the completion of the surgery.
Measured: from 2 hous till 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start10 Jan 2023
- Primary completion1 Jun 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyam Abdelwahab Abdelhamid, Beni-Suef University
- Investigators
- Mahmoud Attia Ali, Professor, Study chair, Anesthesiology,Surgical intensive care & pain management,Faculty of Medicine,Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807605
- Sponsor's protocol ID
- Breast Surgery Analgesia
- Status last verified
- Jan 2023
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Serratus Anterior Plane Block Versus Ultrasound Guided Thoracic Epidural Analgesia for Conservative Breast Surgery: A Comparative Study
- ClinicalTrials.gov ID
- NCT07807605
- Acronym / sponsor ID
- Breast Surgery Analgesia
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 8 Sep 2026 (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.
Regional/local analgesic techniques are an important component of a multimodal analgesic strategy, with the aim of reducing opioid requirements and opioid-related adverse events. This change parallels quality improvement initiatives and the Enhanced Recover after Surgery.
Breast conserving surgery with radiation therapy is today standard therapy for low grade breast cancer. It is safe and preferred therapeutic procedure in all early detected breast cancers ,because it provide the same level of overall survival rates as seen in patients treated with mastectomy ,have been found by several prospective and randomized studies and number of clinical trials .
Detailed description
Acute post-surgical pain leads to delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay.
It is also an important factor leading to the development of chronic persistent post-operative pain in almost half of the patients. Post-operative pain, stress and use of morphine have been elucidated as factors responsible for increased risk of metastasis.
Hence, an effective perioperative pain management of patients undergoing breast surgery is essential. Regional blocks have been considered as one of the modalities for effective perioperative pain control. They have an opioid-sparing effect, and allow early mobilisation and early discharge from hospital.
Ultrasound-guided muscle plane blocks have changed the practice of regional anesthesia for breast surgeries. Different variations of Pecs block have been described with an aim to provide anesthesia and analgesia of the hemi thorax.
Recently described serratus anterior plane (SAP) block was designed to target primarily the thoracic intercostal nerves, providing complete analgesia to the lateral part of the thorax. Compared with Pecs-II, the needle is placed more caudally and posteriorly in SAP block and local anesthetic (LA) is deposited either superficial or deep to the serratus anterior muscle.
Serratus Anterior Plane (SAP) block has been described recently as injection of local Anesthetic (LA) in mid axillary line at the level of the 5th rib either superficial or deep to the serratus anterior (SA) muscle. The intention is to block the thoracic intercostal nerves to provide complete analgesia of the lateral part of the chest.
There are some clinical reports validating its use in breast surgeries. Although serratus anterior plane (SAP) block affects the long thoracic nerve of bell supplying serratus anterior (SA) but there is no mention of blocking the thoracodorsal nerve supplying latissmus dorsi (LD).The thoracodorsal nerve is the sole nerve that supplies latissmus dorsi (LD) and forms a plexus between serratus anterior (SA)and latissmus dorsi (LD).
On the other hand, regarding thoracic epidural analgesia, the results from MRI studies indicate that the spinal cord lies anteriorly within its thecal sac in the thoracic curve and the following measures were found: 5.19 mm in T2, 7.75 mm in T5 and 5.88 mm in T10, this let us say, sufficient distance to permit the careful advancement of a needle (accidentally or intentionally) without reaching the cord and administer anesthetic for a segmental spinal anesthesia. This anatomical explanation was proposed for the absence of spinal cord injury during an accidental perforation during attempted thoracic epidural.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus anterior plane block Group | Active comparator | Drug: Bupivacaine 0.25% Injectable SolutionAbout 35 female patients diagnosed with breast malignancy subjected to Breast Conservative Surgery under general anesthesia by Ultrasound guided serratus anterior plane block anesthesia |
| Thoracic epidural analgesia Group | Active comparator | Drug: Bupivacaine 0.25% Injectable SolutionAbout 35 female patients diagnosed with breast malignancy subjected to Breast Conservative Surgery under general anesthesia by ultrasound guided Thoracic Epidural Analgesia |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients of the American Society of Anesthesiology physical status (І and ІІ) Female patients.
- Female patients diagnosed with breast malignancy
- Patients with Body weight: patients with body mass index less than 35.
Key exclusion criteria (5 listed)
- Uncooperative patient, those with any contraindication for spinal or epidural anesthesia (systemic coagulopathy-local infection)
- Patients with body mass index >35
- Patients with chronic obstructive pulmonary disease
- Patients with anatomic abnormalities
- Patients with allergy to study drugs
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 |
|---|---|---|
| Bupivacaine 0.25% Injectable SolutionAlso: fentanylto compare and evaluate safety, efficacy, benefits and complications of thoracic epidural analgesia and serratus anterior plane block in patients undergoing Conservative breast surgery under general anesthesia. | Drug | Serratus anterior plane block Group, Thoracic epidural analgesia Group |
Primary outcome
Post Operative Pain
Time frame: from 2 hous till 24 hours after the surgery
the duration of effective analgesia from the block till the first analgesic dose is required.the severity of postoperative pain as assessed by the visual analogue scale ((0 = no pain, 10 = most imaginable pain) at 1, 4, 8, 12, and 24 hours after the completion of the surgery.
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 Sep 2026.
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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.
Mahmoud Attia Ali, Professor study chair
Anesthesiology,Surgical intensive care & pain management,Faculty of Medicine,Beni-Suef 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 Bupivacaine 0.25% Injectable Solution in people with Breast Cancer, run by Beni-Suef 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 5 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 Sep 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?
Post Operative Pain (time frame: from 2 hous till 24 hours after the surgery). 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 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.