Quality Study of Anesthetic Technique on Breast Cancer Surgery

Postoperative Pain Clinical Trial

— PQSAT  

Official title:

Effect of Anesthetic Technique on Pain、 Recovery and Satisfaction in Women Undergoing Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499836
• Other study ID #: 20110920A
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2011
• Last updated: January 14, 2014
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 investigators would like to further discern the impact of GA or PVB on the postoperative QoR, pain and satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Quality of Recovery
• Satisfaction

Intervention

Other:
• PVB
paravertebral block

Locations

Country	Name	City	State
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Nai Liang Li

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of recovery		postoperative 6 hour and postoperative day(POD)1	No
Secondary	adverse events		POD1	No
Secondary	Number of patients with a technique failure of the PVB		during operation	No
Secondary	NRS pain score		postoperative 1 hour, 6 hour, and POD1	No
Secondary	Satisfaction		POD1	No