Serratus Plane Block in Preventing Postoperative Pain of Mastectomy

Not Applicable

Completed

• Conditions: Breast Cancer; Serratus Plane Block; Chronic Pain
• Interventions: Procedure: serratus plane block with local anesthetic; Procedure: serratus plane block with saline

• Registration Number: NCT03615430
• Lead Sponsor: Feng Xia

Brief Summary

A prospective, double-blinded randomized controlled, 1-year follow-up study was designed to compare the analgesic effect of serratus plane block (SPB) after breast cancer surgery. Women undergoing radical mastectomy were dIvided into Control group and SPB group. The postoperative acute pain was evaluated by numerical rating scale (NRS) and the effect of preventing chronic pain was assessed at 3, 6, 12 months after surgery by NRS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-23
• Study Start: 2018-08-01
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-03
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• women undergoing radical mastectomy with either sentinel lymph node dissection or axillary lymph node dissection or no axillary lymph node dissection
• between the ages of 18 and 85 yr
• with an American Society of Anesthesiology (ASA) physical status I or II
• without any significant cardiopulmonary, renal and hepatic dysfunction

Exclusion Criteria

• Patients with any previous cancer other than breast cancer
• occurrence of allergy to local anesthetics
• occurrence of opioid-tolerant subjects
• occurrence of consuming analgesics, sedatives, antidepressants or any history of substance abuse before surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPB group	serratus plane block with local anesthetic	Serratus plane block group, 15ml of 0.25% ropivacaine, a widely used local anesthetic for peripheral nerve block, was administered to superficial and deep surface of serratus anterior in SPB group via ultrasound before the surgery
Control group	serratus plane block with saline	saline control group, 15 mL of the saline was administered to superficial and deep surface of serratus anterior in Control group via ultrasound before the surgery

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS) of chronic pain	3 months after surgery	Pain intensity of patients was evaluated by Numerical Rating Scale, rating from 0 (no pain) to 10 (extreme pain) in order to evaluate the effect of SPB in preventing chronic pain

Secondary Outcome Measures

Name	Time	Method
the change trend of Numerical Rating Scale (NRS) after surgery	0-24 hours after operation	Pain intensity of patients was evaluated by Numerical Rating Scale, rating from 0 (no pain) to 10 (extreme pain) in order to evaluate the analgesic effect of SPB
Morphine consumption	0-24 hours after operation	extra need of analgesic

Trial Locations

Locations (1)

Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China