The Analgesic Effect of Ultrasound-guided Double-point Versus Single-point Serratus Anterior Plane Block on Modified Radical Mastectomy：A Randomized Controlled Study
Sponsor study identifier
interventional
57
1 country
1
Study Start
April 1, 2022
Actual (reported)Primary Completion
December 5, 2023
Actual (reported)Study Completion
December 8, 2023
Actual (reported)Nowadays, the incidence of breast cancer is the first number of malignant tumors, and the primary treatment method is surgery. As is known to all, less postoperative complications and enhanced recovery are closely related to effective analgesia. However, postoperative patients often experience moderate pain, while associated with axillary discomfort. Serratus Anterior Plane Block (SAPB) relieves postoperative pain, but traditional single point block method has no effect on axillary discomfort. Therefore, it is necessary to try double point blocks to explore their impact on postoperative analgesia and axillary comfort. This RCT will recruit patients proposed to undergo Modified Radical Mastectomy (MRM) and be randomized to single point or double point groups to evaluate their postoperative pain score and axillary comfort in order to provide clinical guidance.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 8, 2023
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 6, 2021
Actual (reported)March 28, 2022
Actual (reported)April 1, 2022
Actual (reported)December 5, 2023
Actual (reported)December 8, 2023
Actual (reported)Postoperative pain severity at 24 h
Postoperative pain severity at rest and movement measured using a numerical rating scale(NRS) at 24 h. The numerical rating scale (NRS) is a line with numbers from 0 to 10 are spaced evenly across the page. And the NRS is bounded at the left-most end with "no pain" and at the right-most end with "worst pain imaginable". Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. The movement status refers to maximum mobility of the upper arm of the surgical side.
24 hours after the surgery
Pain severity at discharge from PACU and at 6 and 12 and 48 h postoperatively
Respectively at discharge from PACU and at 6 and 12 and 48 h after the surgery;
SAPB will be performed simultaneously in both the third and fifth rib levels.
SAPB will be performed only in the fifth rib level.
A high-frequency linear probe (6-13 MHz) of the ultrasound machine was used to identify the fifth rib in the midaxillary line. The anatomic landmarks of the block were identified: latissimus dorsi, serratus anterior, and the intercostal muscles in the fourth and fifth intercostal levels. After sterilization and draping, an 20-gauge needle was introduced craniocaudally using an in-plane technique. The needle tip was advanced, targeting the plane between the serratus anterior muscle and the fifth rib. Needle position was confirmed by injection of 1-to-2 mL of saline after negative aspiration. And use the same method targeting the plane between the serratus anterior muscle and the third rib.Under real-time visualization, total 30 mL of 0.375% ropivacaine and 0.5 μ g/kg dexmedetomidine mixture will be injected into the two points with 15 ml separately.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Xu J, Ling D, Xu Q, Sun P, Wei S, Gao L, Lou F, Zhang J. Ultrasound-Guided Double-Point Versus Single-Point Serratus Anterior Plane Block for Modified Radical Mastectomy: A Randomized Controlled Trial. Clin J Pain. 2025 Jan 1;41(1):e1256. doi: 10.1097/AJP.0000000000001256.
Jun Zhang, PhD
Fudan University
57 participants (actual enrollment reported by the registry).
First Submitted
December 6, 2021
First Posted
March 28, 2022
Study Start
April 1, 2022
Actual (reported)Postoperative opioid consumption
Respectively at 24 and 48 h after the surgery;
Proportion of rescue analgesia
48 h after the surgery;
Postoperative axillary comfort severity
Respectively at discharge from PACU and at 6 and 12 and 24 and 48 h after the surgery.
Postoperative quality of recovery
Respectively at 24 and 48 h after the surgery.
Changes in mean arterial pressure（MAP） and heart rate during skin peeling and axillary node dissection
Before and after 3 min of incision, before and after 3 min of axillary lymph nodes,respectively.
A high-frequency linear probe (6-13 MHz) of the ultrasound machine was used to identify the fifth rib in the midaxillary line. The anatomic landmarks of the block were identified: latissimus dorsi, serratus anterior, and the intercostal muscles in the fourth and fifth intercostal levels. After sterilization and draping, an 20-gauge needle was introduced craniocaudally using an in-plane technique. The needle tip was advanced, targeting the plane between the serratus anterior muscle and the fifth rib. Needle position was confirmed by injection of 1-to-2 mL of saline after negative aspiration.Under real-time visualization, total 30 mL of 0.375% ropivacaine and 0.5μ g/kg dexmedetomidine mixture will be injected.
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Primary Completion
December 5, 2023
Actual (reported)Study Completion
December 8, 2023
Actual (reported)Last Updated
March 6, 2024
Record last verified: 2023-12
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