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

Nai Liang Li

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Quality of Recovery; Satisfaction

Treatments: Other: PVB

Study type: Interventional

Funder types: Other

Identifiers

NCT01499836

20110920A

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 3 patient groups

general anesthesia and PVB

Experimental group

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.

Treatment:

Other: PVB

sedation and PVB

Experimental group

Description:

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.

Treatment:

Other: PVB

general anesthesia

Active Comparator group

Description:

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

Treatment:

Other: PVB