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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
  Purpose

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
Endpoint Classification: Efficacy Study
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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499836

Contacts
Contact: Nai Liang Li +886-2-2897-0011 ext 1666 lnl@kfsyscc.org

Locations
Taiwan
Koo Foundation Sun Yat-Sen Cancer Center Not yet recruiting
Taipei, Taiwan, 11259
Contact: Li     +886-2-2897-0011        
Sponsors and Collaborators
Nai Liang Li
Investigators
Principal Investigator: Nai Liang Li Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Nai Liang Li, M.D., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01499836     History of Changes
Other Study ID Numbers: 20110920A
Study First Received: December 10, 2011
Last Updated: December 22, 2011
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013