Skip to main content
Clinical Trials/NCT01499836
NCT01499836
Completed
Phase 4

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

Nai Liang Li1 site in 1 country101 target enrollmentJanuary 2012

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Nai Liang Li
Enrollment
101
Locations
1
Primary Endpoint
quality of recovery
Status
Completed
Last Updated
12 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
June 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Nai Liang Li
Responsible Party
Sponsor Investigator
Principal Investigator

Nai Liang Li

M.D.

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • Patient has a physical status between ASA I and III
  • 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

Outcomes

Primary Outcomes

quality of recovery

Time Frame: postoperative 6 hour and postoperative day(POD)1

Secondary Outcomes

  • adverse events(POD1)
  • NRS pain score(postoperative 1 hour, 6 hour, and POD1)
  • Number of patients with a technique failure of the PVB(during operation)
  • Satisfaction(POD1)

Study Sites (1)

Loading locations...

Similar Trials