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

Primary Purpose

Postoperative Pain, Quality of Recovery, Satisfaction

Status

Completed

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

PVB

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Koo Foundation Sun Yat-Sen Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

general anesthesia and PVB

sedation and PVB

general anesthesia

Arm Description

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.

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.

general anesthetics consisting of propofol, cisatracurium and fentanyl for endotracheal intubation and deaflurane for maintenance will be given.

Outcomes

Primary Outcome Measures

quality of recovery

Secondary Outcome Measures

adverse events

Number of patients with a technique failure of the PVB

NRS pain score

Satisfaction

Full Information

NCT ID

NCT01499836

First Posted

December 10, 2011

Last Updated

January 14, 2014

Sponsor

Nai Liang Li

1. Study Identification

Unique Protocol Identification Number

NCT01499836

Brief Title

Quality Study of Anesthetic Technique on Breast Cancer Surgery

Acronym

PQSAT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nai Liang Li

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Quality of Recovery, Satisfaction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

general anesthesia and PVB

Arm Type

Experimental

Arm Description

Arm Title

sedation and PVB

Arm Type

Experimental

Arm Description

Arm Title

general anesthesia

Arm Type

Active Comparator

Arm Description

general anesthetics consisting of propofol, cisatracurium and fentanyl for endotracheal intubation and deaflurane for maintenance will be given.

Intervention Type

Other

Intervention Name(s)

PVB

Intervention Description

paravertebral block

Primary Outcome Measure Information:

Title

quality of recovery

Time Frame

postoperative 6 hour and postoperative day(POD)1

Secondary Outcome Measure Information:

Title

adverse events

Time Frame

POD1

Title

Number of patients with a technique failure of the PVB

Time Frame

during operation

Title

NRS pain score

Time Frame

postoperative 1 hour, 6 hour, and POD1

Title

Satisfaction

Time Frame

POD1

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nai Liang Li

Organizational Affiliation

Koo Foundation Sun Yat-Sen Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Koo Foundation Sun Yat-Sen Cancer Center

City

Taipei

ZIP/Postal Code

11259

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

Quality Study of Anesthetic Technique on Breast Cancer Surgery

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