Efficacy of Preoperative Pectoral Nerve Block for Intraoperative Opioid Sparing Effect and Postoperative Analgesia

Efficacy of Preoperative Ultrasound Guided Pectoral Nerve Block for Intraoperative Opioid Sparing Effect and Postoperative Analgesia in Patients Undergoing Surgery for Breast Cancer.

The purpose of this study is to determine whether pectoral nerves blocks（PECS） would reduces the opioid consumption during the surgery and postoperative pain after breast cancer surgery.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Pecs II block

Detailed Description

Forty adult female participants scheduled for elective breast cancer surgery under general anesthesia are randomly allocated to receive either general anesthesia plus Pecs block(Pecs group, n=20) or general anesthesia alone (control group, n=20).

After arrived in the operating room，all patients undergo operation under total intravenous anesthesia (TIVA) with or without pectoral nerves blocks(PECS) . After anesthesia induction，the participants in the Pecs group receive an ultrasound-guided Pecs block before the start of the operation.

Pecs block technology：After cleaning the infraclavicular and axillary regions , the linear probe is placed below the lateral third of the clavicle. After recognition of the appropriate anatomical structures, then the block is performed . The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .

During operation the remifentanil administration in each group is guided using the surgical pleth index( SPI). the SPI target range was 20 to 50 Anesthetic depth is maintained and continuously adjusted with propofol to achieve Bispectral Index (BIS) between 40 and 60.

primary outcome intraoperative remifentanil consumption secondaty outcome postoperative pain score and rescue analgesic requirement

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 22241
    • Kyung Cheon Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

American Society of Anesthesiologists( ASA) I or II Scheduled for breast cancer surgery

Exclusion Criteria:

Sensitivity to local anesthetic, Bleeding disorders , Receiving anticoagulant, Body mass index (BMI) > 35/kg/m2 , Spine or chest wall deformity , Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pecs group; Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .	Procedure: Pecs II block; After identifying the axillary vein and artery, the ultrasound probe was positioned inferio-laterally, between the 3rd and 4th ribs, and then the pectoralis major and minor, and serratus anterior muscles were confirmed. The needle was advanced in a medio-lateral direction in-plane view of the ultrasound. For the Pecs II block, a total 30 mL of 0.5% ropivacaine was injected. First, the needle tip was advanced into the fascia between the pectoralis major and minor muscles and 10 mL of 0.5% ropivacaine was injected. Thereafter, the needle tip was advanced into the tissue plane between the pectoralis minor and serratus anterior muscles, and 20 mL of 0.5% ropivacaine was injected in a similar manner.
No Intervention: control group; There is no block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Remifentanil Consumption	Intraoperative remifentanil consumption during surgery(whole intraoperative period)	whole intraoperative period

Collaborators and Investigators

• Sponsor: Gachon University Gil Medical Center
• Investigators: Study Chair: Kyung Cheon Lee, Gachon University Gil Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2017
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PENBreast

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No