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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-15

Study Completion Date

2017-06-14

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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group control

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 Type PLACEBO_COMPARATOR

0.9% Nacl

Intervention Type DRUG

patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.9% Nacl 0.4ml/Kg.

group SPB

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.

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.5% ropivacaine 0.4ml/Kg.

Interventions

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Ropivacaine

patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.5% ropivacaine 0.4ml/Kg.

Intervention Type DRUG

0.9% Nacl

patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.9% Nacl 0.4ml/Kg.

Intervention Type DRUG

Other Intervention Names

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local anesthetic Normal saline

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes