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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nai Liang Li, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01499836
First received: December 10, 2011
Last updated: January 14, 2014
Last verified: January 2014

December 10, 2011
January 14, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01499836 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01499836
20110920A
Yes
Nai Liang Li, Sun Yat-sen University
Nai Liang Li
Not Provided
Principal Investigator: Nai Liang Li Sun Yat-sen University
Sun Yat-sen University
January 2014

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