Ultrasound-guided Serratus Plane Block for the Quality of Recovery After Modified Radical Mastectomy

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: 0.9% Nacl; Drug: Ropivacaine

• Registration Number: NCT02691195
• Lead Sponsor: Fujian Provincial Hospital

Brief Summary

Regional anesthesia improves quality of recovery after surgery in many studies. Ultrasound-guided serratus plane block is a novel technique which may be a viable alternative to current regional anesthetic techniques. This randomized, controlled trial is to examine the effects of ultrasound-guided serratus plane block anesthetic on the QoR after breast tumor resection.

Detailed Description

A total of 72 subjects (36 patients for each groups) were enrolled in this study. Patients were allocated to either the general anesthesia group (group control) or SPB (serratus plane block) + general anesthesia groups (group SPB) using randomized central computer-generated sequence software (SAS 19.0). The allocation ratio was 1:1 for the two groups. Group assignment was concealed by opaque sticking envelops. The major research content is to evaluate the quality of recovery using 40 questionnaire (QoR-40).

Study Timeline

• Study First Submitted: 2016-02-15
• Study First Submitted QC: 2016-02-21
• Study First Posted: 2016-02-25
• Study Start: 2016-03-15
• Primary Completion: 2017-06-12
• Study Completion: 2017-06-14
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-03
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

• Patients of American Society of Anesthesiologists' (ASA) Physical Status class I-II scheduled for first modified radical mastectomy were included.

Exclusion Criteria

• Patients with chronic ethanol
• long-term use of psychotropic drugs (e.g. sedative drugs and antidepressant);
• contraindications for serratus plane block including coagulopathy, infection at the puncture site;
• unable to cooperate with this research due to cognitive impairment, psychopathy or not willing for the hospital follow-up;
• administration of other test drugs or joining in other clinical study in 3 months before our study;
• received radiotherapy or chemotherapy before surgery;
• other conditions not allocated for this study out of the researchers' consideration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group control	0.9% Nacl	group control :Before induction of intravenous anesthesia, patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.9% Nacl 0.4ml/Kg.
group SPB	Ropivacaine	group SPB:Before induction of intravenous anesthesia, patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.5% ropivacaine 0.4ml/Kg.

Primary Outcome Measures

Name	Time	Method
The quality of recovery	at 24 hours after surgery	The primary outcome was the quality of recovery, which was assessed at 24 hours after surgery using a 40-item questionnaire (QoR-40).

Secondary Outcome Measures

Name	Time	Method
Postoperative pain intensity	at postoperative hours 0.5, 1, 2, 4, 8 and 24	Postoperative pain intensity was rated at postoperative hours 0.5, 1, 2, 4, 8 and 24 with Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 means no pain and 10 is the worst pain imaginable.

Trial Locations

Locations (1)

Fujian Provincial Hospital; 🇨🇳 Fuzhou, Fujian, China