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

Study Overview
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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.

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).

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

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: 0.9% Nacl


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: group control<br>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. | Drug: 0.9% Nacl<br>* patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.9% Nacl 0.4ml/Kg.<br>* Other names: Normal saline;|
| Experimental: group SPB<br>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. | Drug: Ropivacaine<br>* patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.5% ropivacaine 0.4ml/Kg.<br>* Other names: local anesthetic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The quality of recovery | The primary outcome was the quality of recovery, which was assessed at 24 hours after surgery using a 40-item questionnaire (QoR-40). | at 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain intensity | 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. | at postoperative hours 0.5, 1, 2, 4, 8 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Serratus Plane Block, Quality of recovery