Paravertebral Block (PVB) Combined Pectoral Musculature Blocks for Modified Radical Mastectomy (MRM)

Comparisons the Analgesia of Paravertebral Block Combined With Thoracic Wall Block Versus Paravertebral Block Alone for Modified Radical Mastectomy in Breast Cancer

Previous studies have shown that PVB reduces pain and postoperative nausea and vomiting after breast cancer surgery when used in addition to general anesthesia or sedation. However, major breast cancer surgery involves areas beyond the breast tissue, such as pectoral musculature.

Study Overview

• Status: Completed
• Conditions: Mastectomy, Modified Radical

• Study Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients were that diagnosed to have unilateral breast cancer and undergone modified radical mastectomy using regional anesthesia during Jun 1, 2012 and May 31, 2015.

Description

Inclusion Criteria:

• The American Society of Anesthesiologists (ASA) Physical Status classification I to III
• 20 - 75 years of age
• female gender

Exclusion Criteria:

• body mass index (BMI) ≥ 35 kg/m2
• modified radical mastectomy not performed by the single surgeon (Ben Long Yu)
• anesthesia not performed by the single anesthesiologist (Nai Liang Li)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PECS 0; receiving paravertebral block
PECS 1; receiving paravertebral block and blocks targeting pectoral musculature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative sedation requirement	target controlled infusion (TCI) propofol driven by the Schnider model in effect site control titrated to reach conscious sedation defined as Observer Assessment of Alertness/Sedation score of 2 to 3	during operation

Secondary Outcome Measures

Outcome Measure	Time Frame
time to first request of analgesics	postoperative 12 hours
postoperative analgesic requirement	postoperation to discharge
side effects	postoperation to within 24 hours after discharge

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: April 17, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PVBPEC