We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01499836
First Posted: December 26, 2011
Last Update Posted: January 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nai Liang Li, Sun Yat-sen University
December 10, 2011
December 26, 2011
January 16, 2014
January 2012
April 2013   (Final data collection date for primary outcome measure)
quality of recovery [ Time Frame: postoperative 6 hour and postoperative day(POD)1 ]
Same as current
Complete list of historical versions of study NCT01499836 on ClinicalTrials.gov Archive Site
  • adverse events [ Time Frame: POD1 ]
  • Number of patients with a technique failure of the PVB [ Time Frame: during operation ]
  • NRS pain score [ Time Frame: postoperative 1 hour, 6 hour, and POD1 ]
  • Satisfaction [ Time Frame: POD1 ]
Same as current
Not Provided
Not Provided
 
Quality Study of Anesthetic Technique on Breast Cancer Surgery
Effect of Anesthetic Technique on Pain、 Recovery and Satisfaction in Women Undergoing Breast Surgery
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Postoperative Pain
  • Quality of Recovery
  • Satisfaction
Other: PVB
paravertebral block
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
June 2013
April 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01499836
20110920A
Yes
Not Provided
Not Provided
Nai Liang Li, Sun Yat-sen University
Nai Liang Li
Not Provided
Principal Investigator: Nai Liang Li Koo Foundation Sun Yat-Sen Cancer Center
Sun Yat-sen University
January 2014

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