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

NCT05299021 | Completed

• 1 other identifier: SAPB for MRM 2.0
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mammary Cancer; Serratus Anterior Plane Block; Postoperative Pain

Keywords

Mammary Cancer; Serratus Anterior Plane Block; Postoperative Pain; Axillary Discomfort

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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;

• Postoperative opioid consumption

  Respectively at 24 and 48 h after the surgery;

• Proportion of rescue analgesia

  48 h after the surgery;

Other Outcomes (4)

• 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.

Study Arms (2)

Double-point SAPB

EXPERIMENTAL

SAPB will be performed simultaneously in both the third and fifth rib levels.

Procedure: Double-point SAPB

Single-point SAPB

EXPERIMENTAL

SAPB will be performed only in the fifth rib level.

Procedure: Single-point SAPB

Interventions

Double-point SAPB PROCEDURE

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.

Double-point SAPB

Single-point SAPB PROCEDURE

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.

Single-point SAPB

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Breast cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are proposed to undergo Modified Radical Mastectomy
• Patients with American Society of Anesthesiologists (ASA) physical status I\~III
• aged 18-70 years
• BMI ≤ 35 kg/m2

You may not qualify if:

• Patients with a pre-existing neuropathy or sensory deficit affecting the operative region
• Pregnancy
• Chronic pain or opioid dependence (at least 30 mg of oxycodone or equivalent per day)
• Allergy to local anaesthesia or any component of the proposed multimodal analgesia regimen
• Local or systemic contra-indications to peripheral nerve blocks (local infection at the puncture site, coagulopathy, platelets less than 80\*10\^9/L and prothrombin time more than 15 s)

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• 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.

  PMID: 39475834 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jun Zhang, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of anaesthesiology, Shanghai cancer center

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: March 28, 2022
• Study Start: April 1, 2022
• Primary Completion: December 5, 2023
• Study Completion: December 8, 2023
• Last Updated: March 6, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)