Quality Study of Anesthetic Technique on Breast Cancer Surgery

Study Overview
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Brief Summary
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Previous studies have shown that paravertebral block (PVB) has the potential to reduce pain and side effects after breast surgery when used in addition to general anesthesia or sedation.The investigators would like to further discern the impact of GA or PVB on the postoperative QoR, pain and satisfaction.

Official Title
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Effect of Anesthetic Technique on Pain、 Recovery and Satisfaction in Women Undergoing Breast Surgery

Conditions
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Postoperative Pain, Quality of Recovery, Satisfaction

Intervention / Treatment
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* Other: PVB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a physical status between ASA I and III Female 18 - 70 years of age Patients able to read a newspaper in Chinese. Elective unilateral wide excision/simple mastectomy and SLNB/ALND Patient has signed an informed consent Without contraindication of GA or PVB Body mass index (BMI) less than 24 kg/m2 Exclusion Criteria: ASA > III inability to provide informed consent Bleeding disorders Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs) Allergy to amide-type local anesthetics or NSAIDs Infection at the thoracic paravertebral injection site Pregnancy or breast-feeding Severe spine or chest wall deformity body mass index equal to or more than 24 kg/m2 patients with major psychosis or drug and alcohol abuse patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease Patients with significant visual impairment or other physical disability that precludes complete cooperation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: general anesthesia and PVB<br>general anesthetics consisting of propofol, cisatracurium and fentanyl for endotracheal intubation and deaflurane for maintenance will be given. After intubation, paravertebral injections will be performed under ultrasound guidance. | Other: PVB<br>* paravertebral block<br>|
| Experimental: sedation and PVB<br>After sedation with midazolam and fentanyl, the patients in sedation and PVB group will receive PVB. paravertebral injections will be performed under ultrasound guidance.Intraoperative sedation will be provided with propofol titrated to moderate sedation. | Other: PVB<br>* paravertebral block<br>|
| Active Comparator: general anesthesia<br>general anesthetics consisting of propofol, cisatracurium and fentanyl for endotracheal intubation and deaflurane for maintenance will be given. | Other: PVB<br>* paravertebral block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of recovery |  | postoperative 6 hour and postoperative day(POD)1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | POD1 | 
| Number of patients with a technique failure of the PVB |  | during operation | 
| NRS pain score |  | postoperative 1 hour, 6 hour, and POD1 | 
| Satisfaction |  | POD1 |