MastectomyPECSNCT07881237
Effect of Serratus and Pectoralis II Plane Block Versus Pectoralis II Alone on Acute Postoperative Pain After Mastectomy
A study testing Serratus Anterior Plane Block (SAPB) group and Pectoral nerve block (PECS) in people with Mastectomy and Mastectomy Plus Axillary Lymph Node Dissection, run by Lebanese American University at 1 site in Lebanon.
Trial summary
The goal of this randomized controlled clinical trial is to determine whether adding a serratus anterior plane block (SAPB) to a pectoralis II (PECS II) block improves pain relief and reduces the need for opioids in adult women undergoing breast removal surgery (mastectomy), with or without removal of lymph nodes from… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy, Mastectomy Plus Axillary Lymph Node Dissection, Nerve Block; Pain Medication
- What is being tested?
- Serratus Anterior Plane Block (SAPB) group and Pectoral nerve block (PECS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteLebanon
- Study dates
- Dec 2026to Mar 2029
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 years or older
- ASA physical status I-III
- Scheduled for elective mastectomy with or without axillary dissection
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- ASA physical status greater than III
- Refusal to participate
- Inability to use PCA
- Known allergy or contraindication to local anesthetics
- Pregnancy
- Infection at the planned injection site
Show all 14Show fewer
- Uncorrected coagulopathy
- Chronic opioid use
- Inability to reliably assess or communicate pain scores
- Previous major breast surgery on the operative side
- Severe cardiac, renal, hepatic, or respiratory disease
- Neurological or neuromuscular disorders
- Failure of the regional block technique
- Chronic pain in the breast area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site
Lebanese American University Medical Center-Rizk Hospital
Beirut
About this study
Official title: Effect of Combination of Serratus and Pectoralis II Plane Block Versus Pectoralis II Plane Block Alone on Acute Postoperative Pain After Mastectomy
The goal of this randomized controlled clinical trial is to determine whether adding a serratus anterior plane block (SAPB) to a pectoralis II (PECS II) block improves pain relief and reduces the need for opioids in adult women undergoing breast removal surgery (mastectomy), with or without removal of lymph nodes from the armpit.
The main questions it aims to answer are:
Read more
- Does adding an SAPB to a PECS II block reduce the total amount of opioids needed in the recovery room and during the first 24 hours after surgery?
- Does the combination reduce the amount of opioid pain medication needed during surgery?
- Does the combination improve pain levels during the first 24 hours after surgery?
- Does the combination affect the occurrence of side effects or complications, including nausea, vomiting, drowsiness, serious reactions to the local anesthetic, and collapsed lung?
Researchers will compare a group receiving both SAPB and PECS II blocks with a group receiving only a PECS II block to determine whether the combination improves pain relief and reduces opioid requirements.
Participants will:
- Be randomly assigned to one of two groups, with both groups receiving general anesthesia for surgery.
- Receive the assigned nerve block or blocks using ultrasound guidance and a local anesthetic medicine called ropivacaine.
- Receive postoperative pain relief through a patient-controlled analgesia (PCA) device, which allows them to administer prescribed doses of morphine when needed, in addition to other pain medications.
- Have their opioid use and pain levels assessed at scheduled intervals during the first 24 hours after surgery.
- Be monitored for additional pain medication requirements, side effects, block-related complications, and changes in heart rate and blood pressure during surgery.
- Conditions
- Mastectomy, Mastectomy Plus Axillary Lymph Node Dissection, Nerve Block; Pain Medication, Pectoralis Nerve Block, Serratus Anterior Muscle Plane Block, Opioid Consumption
- Being tested
- Serratus Anterior Plane Block (SAPB) group, Pectoral nerve block (PECS)
- Keywords
- Mastectomy, Breast cancer, PECS II block, Pectoralis nerves block, Serratus anterior plane block, Combined regional blocks, Ultrasound-guided regional anesthesia, Acute postoperative pain, Opioid consumption, Opioid-sparing analgesia
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Anterior Plane Block (SAPB) groupProcedure or surgery
An experienced anesthesiologist will perform a single deep serratus anterior plane block before induction of general anesthesia under ultrasound guidance and aseptic conditions, injecting 15-20 mL of ropivacaine 0.375%, adjusted according to body weight, into the plane deep to the serratus anterior muscle. The total ropivacaine dose across both blocks will not exceed 3 mg/kg.
Pectoral nerve block (PECS)Procedure or surgery
Also called PECS II
An experienced anesthesiologist will perform a single PECS II block before induction of general anesthesia under ultrasound guidance and aseptic conditions, injecting a total of 20 mL of ropivacaine 0.375% into the appropriate interfascial planes.
| Study group | Role | What they receive |
|---|---|---|
| PECS II Block Alone | Active comparator | Participants will receive PECS II alone before general anesthesia, with standardized perioperative multimodal analgesia and postoperative morphine patient-controlled analgesia and non-opioid pain medications. Receives: Procedure: Pectoral nerve block (PECS) |
| PECS II Block Plus Serratus Anterior Plane Block SAPB | Experimental | Participants will receive PECS II combined with a deep serratus anterior plane block before general anesthesia. General anesthesia and perioperative and postoperative analgesia will be standardized as in the active comparator arm. Receives: Procedure: Serratus Anterior Plane Block (SAPB) group; Procedure: Pectoral nerve block (PECS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative perioperative opioid consumption till 24 hours postop
Total opioid administered intraoperatively and during the first 24 hours after surgery, including PACU rescue morphine and morphine delivered through patient-controlled analgesia. Consumption will be obtained from anesthesia intraoperative recirds, PACU medication records, and PCA logs.
Measured: From start of surgery till 24 hours postop; cumulative consumption postop will be recorded at 1, 2, 4, 6, 12, 18, and 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lebanese American University
- Sponsor type
- University, hospital or other
- Collaborators
- Lebanese American University Medical Center
- Responsible party
- Principal investigator, Hanane Barakat, Lebanese American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881237
- Sponsor's protocol ID
- LAU PIRF 2026
- Other IDs
- IRB
- Acronym
- PECS
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combination of Serratus and Pectoralis II Plane Block Versus Pectoralis II Plane Block Alone on Acute Postoperative Pain After Mastectomy
- ClinicalTrials.gov ID
- NCT07881237
- Acronym / sponsor ID
- PECS / LAU PIRF 2026
- Conditions
- Mastectomy, Mastectomy Plus Axillary Lymph Node Dissection, Nerve Block; Pain Medication, Pectoralis Nerve Block, Serratus Anterior Muscle Plane Block, Opioid Consumption
- Keywords
- Mastectomy, Breast cancer, PECS II block, Pectoralis nerves block, Serratus anterior plane block, Combined regional blocks, Ultrasound-guided regional anesthesia, Acute postoperative pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lebanese American UniversityUniversity, hospital or other
- Collaborators
- Lebanese American University Medical Center
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 19 Oct 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.
The goal of this randomized controlled clinical trial is to determine whether adding a serratus anterior plane block (SAPB) to a pectoralis II (PECS II) block improves pain relief and reduces the need for opioids in adult women undergoing breast removal surgery (mastectomy), with or without removal of lymph nodes from the armpit.
The main questions it aims to answer are:
- Does adding an SAPB to a PECS II block reduce the total amount of opioids needed in the recovery room and during the first 24 hours after surgery?
- Does the combination reduce the amount of opioid pain medication needed during surgery?
- Does the combination improve pain levels during the first 24 hours after surgery?
- Does the combination affect the occurrence of side effects or complications, including nausea, vomiting, drowsiness, serious reactions to the local anesthetic, and collapsed lung?
Researchers will compare a group receiving both SAPB and PECS II blocks with a group receiving only a PECS II block to determine whether the combination improves pain relief and reduces opioid requirements.
Participants will:
- Be randomly assigned to one of two groups, with both groups receiving general anesthesia for surgery.
- Receive the assigned nerve block or blocks using ultrasound guidance and a local anesthetic medicine called ropivacaine.
- Receive postoperative pain relief through a patient-controlled analgesia (PCA) device, which allows them to administer prescribed doses of morphine when needed, in addition to other pain medications.
- Have their opioid use and pain levels assessed at scheduled intervals during the first 24 hours after surgery.
- Be monitored for additional pain medication requirements, side effects, block-related complications, and changes in heart rate and blood pressure during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PECS II Block Alone | Active comparator | Procedure: Pectoral nerve block (PECS)Participants will receive PECS II alone before general anesthesia, with standardized perioperative multimodal analgesia and postoperative morphine patient-controlled analgesia and non-opioid pain medications. |
| PECS II Block Plus Serratus Anterior Plane Block SAPB | Experimental | Procedure: Serratus Anterior Plane Block (SAPB) group, Procedure: Pectoral nerve block (PECS)Participants will receive PECS II combined with a deep serratus anterior plane block before general anesthesia. General anesthesia and perioperative and postoperative analgesia will be standardized as in the active comparator arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged 18 years or older
- ASA physical status I-III
- Scheduled for elective mastectomy with or without axillary dissection
- Ability to understand the study procedures and provide written informed consent
Key exclusion criteria (14 listed)
- ASA physical status greater than III
- Refusal to participate
- Inability to use PCA
- Known allergy or contraindication to local anesthetics
- Pregnancy
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 |
|---|---|---|
| Serratus Anterior Plane Block (SAPB) groupAn experienced anesthesiologist will perform a single deep serratus anterior plane block before induction of general anesthesia under ultrasound guidance and aseptic conditions, injecting 15-20 mL of ropivacaine 0.375%, adjusted according to body weight, into the plane deep to the serratus anterior muscle. The total ropivacaine dose across both blocks will not exceed 3 mg/kg. | Procedure or surgery | PECS II Block Plus Serratus Anterior Plane Block SAPB |
| Pectoral nerve block (PECS)Also: PECS IIAn experienced anesthesiologist will perform a single PECS II block before induction of general anesthesia under ultrasound guidance and aseptic conditions, injecting a total of 20 mL of ropivacaine 0.375% into the appropriate interfascial planes. | Procedure or surgery | PECS II Block Alone, PECS II Block Plus Serratus Anterior Plane Block SAPB |
Primary outcome
Cumulative perioperative opioid consumption till 24 hours postop
Time frame: From start of surgery till 24 hours postop; cumulative consumption postop will be recorded at 1, 2, 4, 6, 12, 18, and 24 hours.
Total opioid administered intraoperatively and during the first 24 hours after surgery, including PACU rescue morphine and morphine delivered through patient-controlled analgesia. Consumption will be obtained from anesthesia intraoperative recirds, PACU medication records, and PCA logs.
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 19 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus Anterior Plane Block (SAPB) group and Pectoral nerve block (PECS) in people with Mastectomy and Mastectomy Plus Axillary Lymph Node Dissection, run by Lebanese American University at 1 site in Lebanon.
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 14 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: opening soon, as of the sponsor's last update on 19 Oct 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 Lebanon. 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 Hanane Barakat, MD (+9613612009, hanane.barakat@lau.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative perioperative opioid consumption till 24 hours postop (time frame: From start of surgery till 24 hours postop; cumulative consumption postop will be recorded at 1, 2, 4, 6, 12, 18, and 24 hours.). 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 19 Oct 2026.