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Completed

NCT Number: NCT03210220

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

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.

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Key information

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kyung Cheon Lee

Incheon, 22241, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PECS II block

Procedure

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.

Primary outcomes

  1. Intraoperative Remifentanil Consumption

    Time frame: whole intraoperative period

    Intraoperative remifentanil consumption during surgery(whole intraoperative period)

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jul 6, 2017
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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