Postoperative pain management is crucial for patients undergoing mastectomy for breast cancer. Regional analgesia techniques, such as the Thoracic Paravertebral Block (TPVB), are commonly used to reduce pain and opioid consumption; however, TPVB carries potential risks, including pneumothorax. Interfascial plane blocks, specifically the Pectoral Nerve II (PECS II) block combined with the Superficial Parasternal Intercostal Plane (PIP) block, have emerged as alternative techniques to provide comprehensive analgesia to both the lateral and anterior chest wall.
The purpose of this randomized controlled trial is to evaluate and compare the analgesic efficacy and quality of postoperative recovery between a combination of ultrasound-guided PECS II and PIP blocks versus the standard Thoracic Paravertebral Block (TPVB) in patients undergoing mastectomy with or without axillary lymph node dissection (ALND).
Participants will be randomly assigned to receive either the combined PECS II and PIP block or the TPVB following general anesthesia induction. Pain scores, total opioid consumption, time to first analgesic request, quality of recovery using the QoR-15 questionnaire, and potential block-related complications will be monitored and compared over the 24-hour postoperative period.
Female patients aged 18 to 60 years.
Scheduled for breast cancer surgery (mastectomy with or without axillary lymph node dissection [ALND]).
American Society of Anesthesiologists (ASA) physical status I to III.
Provided signed written informed consent to participate in the study.
Patient refusal to participate in the study.
Known allergy to local anesthetics or study medications (e.g., bupivacaine, ketorolac, morphine).
Coagulation disorders or coagulopathy.
Mastectomy procedure with immediate breast reconstruction.
Parallel
Combined PECS II and Superficial PIP Block
Procedure/SurgeryUltrasound-guided regional nerve block administration consisting of PECS II block (25 mL 0.25% Bupivacaine) and superficial PIP block (10 mL 0.25% Bupivacaine) post-induction of general anesthesia prior to surgical incision.
Thoracic paravertebral block (TPVB)
Procedure/SurgeryUltrasound-guided regional nerve block administration consisting of TPVB with 0.25% Bupivacaine (5 mL at T4 level and 5 mL at T6 level) post-induction of general anesthesia prior to surgical incision.
Postoperative Quality of Recovery Score (QoR-15)
Patient-reported quality of recovery assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, where higher scores indicate better overall recovery quality post-surgery.
Postoperative Pain Severity (NRS)
Pain severity evaluated using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Measurements are recorded separately at rest and during active movement (shoulder joint movement / arm elevation).
Duration of Analgesia
Time elapsed from the completion of surgery (extubation/arrival at recovery room) to the patient's first request or activation of the Patient-Controlled Analgesia (PCA) morphine device. Measured in minutes/hours.
Regional Block Procedure Execution Time
Total time taken to perform the assigned regional block, measured in seconds/minutes from initial patient positioning and USG scanning until the completion of local anesthetic injection.
Block-Related Complications
Number of participants experiencing procedure- or drug-related complications, including Local Anesthetic Systemic Toxicity (LAST), injection site hematoma, injection site infection, and pneumothorax.
Click on the lead sponsor to view all of their trials.