Quality Study of Anesthetic Technique on Breast Cancer Surgery

NCT01499836 | Completed Phase 4 DMC

• 1 other identifier: 20110920A
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Quality of Recovery; Satisfaction

Outcome Measures

Primary Outcomes (1)

• quality of recovery

  postoperative 6 hour and postoperative day(POD)1

Secondary Outcomes (4)

• adverse events

  POD1

• Number of patients with a technique failure of the PVB

  during operation

• NRS pain score

  postoperative 1 hour, 6 hour, and POD1

• Satisfaction

  POD1

Study Arms (3)

general anesthesia and PVB

EXPERIMENTAL

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.

Other: PVB

sedation and PVB

EXPERIMENTAL

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.

Other: PVB

general anesthesia

ACTIVE COMPARATOR

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

Other: PVB

Interventions

PVB OTHER

paravertebral block

general anesthesia; general anesthesia and PVB; sedation and PVB

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nai Liang Li: lead

Study Sites (1)

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan, 11259, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative; Personal Satisfaction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Study Officials

• Nai Liang Li

  Koo Foundation Sun Yat-Sen Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 10, 2011
• First Posted: December 26, 2011
• Study Start: January 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 16, 2014

Record last verified: 2014-01

Locations

TW (1)