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Not yet recruitingNCT07881237PECSUpdated Oct 19, 2026

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

An interventional study of Serratus Anterior Plane Block (SAPB) group and Pectoral nerve block (PECS) in Mastectomy, Mastectomy Plus Axillary Lymph Node Dissection and Nerve Block; Pain Medication, sponsored by Lebanese American University. Not yet recruiting at 1 site in Lebanon. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Lebanese American University · Not applicable, Interventional, and Treatment

Updated Oct 19, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.
02

Conditions studied

  • 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

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
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 80 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Lebanese American University is the lead sponsor of 16 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    PECS II Block Alone

    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.

    Procedure: Pectoral nerve block (PECS)

  • Experimental
    PECS II Block Plus Serratus Anterior Plane Block SAPB

    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.

    Procedure: Serratus Anterior Plane Block (SAPB) group · Procedure: Pectoral nerve block (PECS)

Interventions

  • ProcedureSerratus Anterior Plane Block (SAPB) group

    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.

  • ProcedurePectoral nerve block (PECS)

    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.

    Also known as: PECS II

06

What researchers measure

Primary outcomes

  1. 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.

    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.

07

Study locations

1 site
  • Lebanese American University Medical Center-Rizk Hospital
    Beirut, Lebanon
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.

Of 2,272 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 24 months is below that.

Counting every sponsor, half of 2,345 studies reached it within 34 months; a quarter within 16 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2026
First posted
Oct 19, 2026
StartEst.
Dec 2026
Primary completionEst.
Dec 2028
CompletionEst.
Mar 2029
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07881237
Lead sponsor
Lebanese American University
Collaborators
Lebanese American University Medical Center
Responsible party
Hanane Barakat (Clinical associate professor of anesthesiology, Lebanese American University) — Principal investigator
First posted
Oct 19, 2026
Start date
Dec 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Mar 2029 (estimated)
Last update
Oct 19, 2026

Study contacts

Hanane Barakat, MD
Contact
hanane.barakat@lau.edu.lb
+9613612009

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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