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

NCT03210220 | Completed Results

• 1 other identifier: PENBreast
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Intraoperative Remifentanil Consumption

  Intraoperative remifentanil consumption during surgery(whole intraoperative period)

  whole intraoperative period

Study Arms (2)

pecs group

EXPERIMENTAL

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

control group

NO INTERVENTION

There is no block.

Interventions

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.

pecs group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gachon University Gil Medical Center: lead

Study Sites (1)

Kyung Cheon Lee

Incheon, 22241, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr Junju Choi
• Organization: Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University

jjchoi2@gilhospital.com

82-32-460-3636

Study Officials

• Kyung Cheon Lee

  Gachon University Gil Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistance professor

Model Details: Patients either received the Pecs II block (Pecs group) or did not receive it (control group).

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 6, 2017
• Study Start: August 29, 2017
• Primary Completion: December 30, 2018
• Study Completion: August 1, 2019
• Last Updated: November 18, 2019
• Results First Posted: November 18, 2019

Record last verified: 2019-10

Locations

KR (1)