Quality Study of Anesthetic Technique on Breast Cancer Surgery

NCT ID: NCT01499836

Last Updated: 2014-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain Quality of Recovery Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PVB

Intervention Type OTHER

paravertebral block

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.

Group Type EXPERIMENTAL

PVB

Intervention Type OTHER

paravertebral block

general anesthesia

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

Group Type ACTIVE_COMPARATOR

PVB

Intervention Type OTHER

paravertebral block

Interventions

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PVB

paravertebral block

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nai Liang Li

OTHER

Sponsor Role lead

Responsible Party

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Nai Liang Li

M.D.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nai Liang Li

Role: PRINCIPAL_INVESTIGATOR

Koo Foundation Sun Yat-Sen Cancer Center

Locations

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Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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20110920A

Identifier Type: -

Identifier Source: org_study_id

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