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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210220
Recruitment Status : Completed
First Posted : July 6, 2017
Results First Posted : November 18, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Jung Ju Choi, Gachon University Gil Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Pecs II block Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients either received the Pecs II block (Pecs group) or did not receive it (control group).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: One anesthesiologist (JJC) performed all blocks in the Pecs group enrolled patients. After the intervention, the participants and the investigator responsible for the study outcome assessment were blinded.
Primary Purpose: Health Services Research
Official Title: Efficacy of Preoperative Ultrasound Guided Pectoral Nerve Block for Intraoperative Opioid Sparing Effect and Postoperative Analgesia in Patients Undergoing Surgery for Breast Cancer.
Actual Study Start Date : August 29, 2017
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.



Primary Outcome Measures :
  1. Intraoperative Remifentanil Consumption [ Time Frame: whole intraoperative period ]
    Intraoperative remifentanil consumption during surgery(whole intraoperative period)



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210220


Locations
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Korea, Republic of
Kyung Cheon Lee
Incheon, Korea, Republic of, 22241
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
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Study Chair: Kyung Cheon Lee Gachon University Gil Medical Center
  Study Documents (Full-Text)

Documents provided by Jung Ju Choi, Gachon University Gil Medical Center:
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Responsible Party: Jung Ju Choi, assistance professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT03210220    
Other Study ID Numbers: PENBreast
First Posted: July 6, 2017    Key Record Dates
Results First Posted: November 18, 2019
Last Update Posted: November 18, 2019
Last Verified: October 2019

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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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases