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

This study has been completed.
Information provided by (Responsible Party):
Nai Liang Li, Sun Yat-sen University Identifier:
First received: December 10, 2011
Last updated: January 14, 2014
Last verified: January 2014
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.

Condition Intervention Phase
Postoperative Pain Quality of Recovery Satisfaction Other: PVB Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Anesthetic Technique on Pain、 Recovery and Satisfaction in Women Undergoing Breast Surgery

Resource links provided by NLM:

Further study details as provided by Nai Liang Li, Sun Yat-sen University:

Primary Outcome Measures:
  • quality of recovery [ Time Frame: postoperative 6 hour and postoperative day(POD)1 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 101
Study Start Date: January 2012
Study Completion Date: June 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: PVB
paravertebral block
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.
Other: PVB
paravertebral block
Active Comparator: general anesthesia
general anesthetics consisting of propofol, cisatracurium and fentanyl for endotracheal intubation and deaflurane for maintenance will be given.
Other: PVB
paravertebral block


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01499836

Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan, 11259
Sponsors and Collaborators
Nai Liang Li
Principal Investigator: Nai Liang Li Sun Yat-sen University
  More Information

Responsible Party: Nai Liang Li, M.D., Sun Yat-sen University Identifier: NCT01499836     History of Changes
Other Study ID Numbers: 20110920A
Study First Received: December 10, 2011
Last Updated: January 14, 2014

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on July 21, 2017