NCT05299021

Serratus Anterior Plane Block for Modified Radical Mastectomy: Double-point VS Single-point

The Analgesic Effect of Ultrasound-guided Double-point Versus Single-point Serratus Anterior Plane Block on Modified Radical Mastectomy：A Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The conventional SAPB, which often performs single point block from the level of the fifth rib, does not completely relieve postoperative pain in patients with axillary lymph node dissection, probably due to insufficient range of local anesthetic diffusion.Anatomical study indicated that with a double point SAPB at the third and fifth rib levels, respectively, the local anesthetic diffusion range can reach the axillary level and may provide better analgesic effects. However, the support of clinical data is lacking.Therefore, the hypothesis of this study is that double point SAPB will provide better postoperative analgesia compared with conventional single point SAPB in patients undergoing modified radical mastectomy.This study will include 60 patients proposed to undergo modified radical mastectomy, allocated to the Double-point or Single-point group in a 1:1 ratio, randomly.The Double-point group will perform a double point SAPB, which is a combined block at the third and fifth rib levels, respectively.The Single-point group will undergo a single point SAPB, traditionally performed at the level of the fifth rib.Observation outcomes included changes in blood pressure and heart rate during dissection of skin and dissection of axillary lymph nodes, postoperative pain scores, axillary comfort, recovery quality, and related complications and postoperative hospital stay.Therefore, the objective is to investigate whether this simple technical modification can better reduce postoperative pain and promote rehabilitation in patients with modified radical mastectomy.

Conditions

• Mammary Cancer
• Serratus Anterior Plane Block
• Postoperative Pain

Interventions

Type	Name	Description
PROCEDURE	Double-point SAPB	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.
PROCEDURE	Single-point SAPB	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.

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-12-05
• Completion: 2023-12-08
• First posted: 2022-03-28
• Last updated: 2024-03-06

Locations

1 site across 1 country: China