Quality Study of Anesthetic Technique on Breast Cancer Surgery (PQSAT)

This study is not yet open for participant recruitment.

Verified December 2011 by Sun Yat-sen University

Sponsor:

Information provided by (Responsible Party):

Nai Liang Li, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT01499836

First received: December 10, 2011

Last updated: December 22, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 10, 2011

Last Updated Date

December 22, 2011

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

quality of recovery [ Time Frame: postoperative 6 hour and postoperative day(POD)1 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01499836 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

adverse events [ Time Frame: POD1 ] [ Designated as safety issue: No ]
Number of patients with a technique failure of the PVB [ Time Frame: during operation ] [ Designated as safety issue: No ]
NRS pain score [ Time Frame: postoperative 1 hour, 6 hour, and POD1 ] [ Designated as safety issue: No ]
Satisfaction [ Time Frame: POD1 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Quality Study of Anesthetic Technique on Breast Cancer Surgery

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Postoperative Pain
Quality of Recovery
Satisfaction

Intervention ^ICMJE

Other: PVB

paravertebral block

Study Arm (s)

Experimental: general anesthesia and 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.

Intervention: Other: PVB
Experimental: sedation and 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.

Intervention: Other: PVB
Active Comparator: general anesthesia
general anesthetics consisting of propofol, cisatracurium and fentanyl for endotracheal intubation and deaflurane for maintenance will be given.

Intervention: Other: PVB

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

January 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Nai Liang Li

+886-2-2897-0011 ext 1666

lnl@kfsyscc.org

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01499836

Other Study ID Numbers ^ICMJE

20110920A

Has Data Monitoring Committee

Yes

Responsible Party

Nai Liang Li, Sun Yat-sen University

Study Sponsor ^ICMJE

Nai Liang Li

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Nai Liang Li

Sun Yat-sen University

Information Provided By

Sun Yat-sen University

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top