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
Conditions
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
Brief 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.
Interventions
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.
Sponsors
Lebanese American University
Lebanese American University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Lebanon
Contacts
CONTACTHanane Barakat, MD
Outcome results
None listed