Quality Study of Anesthetic Technique on Breast Cancer Surgery

Phase 4

Completed

• Conditions: Postoperative Pain; Quality of Recovery; Satisfaction
• Interventions: Other: PVB

• Registration Number: NCT01499836
• Lead Sponsor: Nai Liang Li

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-10
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-26
• Study Start: 2012-01
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
general anesthesia and PVB	PVB	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.
sedation and PVB	PVB	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.
general anesthesia	PVB	general anesthetics consisting of propofol, cisatracurium and fentanyl for endotracheal intubation and deaflurane for maintenance will be given.

Primary Outcome Measures

Name	Time	Method
quality of recovery	postoperative 6 hour and postoperative day(POD)1

Secondary Outcome Measures

Name	Time	Method
adverse events	POD1
NRS pain score	postoperative 1 hour, 6 hour, and POD1
Number of patients with a technique failure of the PVB	during operation
Satisfaction	POD1

Trial Locations

Locations (1)

Koo Foundation Sun Yat-Sen Cancer Center; 🇨🇳 Taipei, Taiwan