Effect of Serratus and Pectoralis II Plane Block Versus Pectoralis II Alone on Acute Postoperative Pain After Mastectomy

NCT07881237 — Not applicable, Not yet recruiting, 80 participants, Lebanese American University

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Effect of Combination of Serratus and Pectoralis II Plane Block Versus Pectoralis II Plane Block Alone on Acute Postoperative Pain After Mastectomy

Registry	NCT07881237, acronym PECS
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	80 (Estimated)
Sponsor	Lebanese American University (Other); collaborators: Lebanese American University Medical Center
Conditions	Mastectomy, Mastectomy Plus Axillary Lymph Node Dissection, Nerve Block; Pain Medication, Pectoralis Nerve Block, Serratus Anterior Muscle Plane Block, Opioid Consumption, Opioid Analgesic Adverse Reaction
Interventions	Serratus Anterior Plane Block (SAPB) group, Pectoral nerve block (PECS) (Procedure)
Dates	start 2026-12-01 (estimated), primary completion 2028-12-01 (estimated), completion 2029-03-01 (estimated), first posted 2026-10-19, last updated 2026-10-19
Locations	1 site in Lebanon

-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 the armpit.

The main questions it aims to answer are:

1. 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?
2. Does the combination reduce the amount of opioid pain medication needed during surgery?
3. Does the combination improve pain levels during the first 24 hours after surgery?
4. 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:

1. Be randomly assigned to one of two groups, with both groups receiving general anesthesia for surgery.
2. Receive the assigned nerve block or blocks using ultrasound guidance and a local anesthetic medicine called ropivacaine.
3. 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.
4. Have their opioid use and pain levels assessed at scheduled intervals during the first 24 hours after surgery.
5. Be monitored for additional pain medication requirements, side effects, block-related complications, and changes in heart rate and blood pressure during surgery.

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+Arms and interventions

Arm	Type	Interventions	Description
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.

Serratus Anterior Plane Block (SAPB) group (Procedure): 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), also known as 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.

+Outcome measures

Primary outcomes

Cumulative perioperative opioid consumption till 24 hours postop [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.

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

+Locations (1)

Facility	City	Country	Status
Lebanese American University Medical Center-Rizk Hospital	Beirut	Lebanon