Status:
COMPLETED
Quality Study of Anesthetic Technique on Breast Cancer Surgery
Lead Sponsor:
Nai Liang Li
Conditions:
Postoperative Pain
Quality of Recovery
Eligibility:
FEMALE
18-70 years
Phase:
PHASE4
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 investigat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01499836
Start Date
January 1 2012
End Date
June 1 2013
Last Update
January 16 2014
Active Locations (1)
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1
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan, Taiwan, 11259