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

Not Applicable

Completed

• Conditions: Serratus Anterior Plane Block; Mammary Cancer; Postoperative Pain
• Interventions: Procedure: Double-point SAPB; Procedure: Single-point SAPB

• Registration Number: NCT05299021
• Lead Sponsor: Fudan University

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.

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.

Study Timeline

• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-28
• Study Start: 2022-04-01
• Status Verified: 2023-12
• Primary Completion: 2023-12-05
• Study Completion: 2023-12-08
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

Inclusion Criteria

• 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

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Exclusion Criteria

• 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double-point SAPB	Double-point SAPB	SAPB will be performed simultaneously in both the third and fifth rib levels.
Single-point SAPB	Single-point SAPB	SAPB will be performed only in the fifth rib level.

Primary Outcome Measures

Name	Time	Method
Postoperative pain severity at 24 h	24 hours after the surgery	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	Respectively at 24 and 48 h after the surgery;	At the end of surgery, patients use postoperative controlled analgesia pump, equip with 0.75 μg / ml sufentanil without background dose, locking time is 10min, and each controlled dose is 2 ml. The cumulative amount of sufentanil used at 24 and 48 hours after surgery will be recorded separately.
Proportion of rescue analgesia	48 h after the surgery;	Rescue analgesia was started when NRS ≥ 4, with Flurbiprofen Axetil 50mg i. v. The proportion of patients who required at least one rescue analgesia at 48 hours after surgery will be recorded.
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;	Secondary analgesic outcomes included: pain severity at rest and movement measured using a NRS at discharge from PACU and at 6 and 12 and 48 h postoperatively;

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China