Regional Anesthesia and Partial Mastectomy

NCT04824599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-09-07

No results posted yet for this study

Summary

Pectoralis nerves plane block (PECS) first described by Blanco in 2011 has become part of postoperative pain management in breast surgery, thoracic surgery and thoracic trauma. The combination of low complication risk and easiness in mastering of PECS block has made it an interesting alternative to thoracic epidural anesthesia (TEDA) and paravertebral blockade (PVB) for pain treatment after breast surgery. Several studies showed good results when PECS was compared to PVB. PECS blockade however is a procedure requiring some resources in the operating room. An alternative approach is to inject local anesthetics (LA) in the operation field by the surgeon.

The hypothesis' tested in this study is primarily: that PECS blockade is superior to LA being injected by surgeon in the operating field measured by end points such as: post-operative pain, post-operative analgesics use, post-operative nausea or vomiting (PONV) and length of stay in the post anesthesia care unit (PACU).

Conditions

  • Breast Neoplasm

Interventions

PROCEDURE

PECS II

Pectoral nerves block (PECS II) is performed with the help of ultrasound. Two injection are performed in two fascial planes. One between pectoralis major muscle and serratus anterior muscle. Second one between pectoralis major and minor muscles.

PROCEDURE

Local anesthetic infiltration

Ropivacaine is administered by surgeon prior to scrubbing and following the removal of the tumor.

PROCEDURE

Subcutaneus local anesthetic infiltration

Ropivacaine is administered by the surgeon at the end of surgery

DRUG

Ropivacaine

Local anesthetic ropivacaine is administered in both study arms according to the study protocol

DEVICE

bk medical Flex Focus 500 Ultrasound Machine

Ultrasound with linear probe is performed. Using in-plane technique a correct placement of the injection needle is secured.

Sponsors & Collaborators

  • Karlstad Central Hospital

    lead OTHER

Principal Investigators

  • Ragnar Henningsson, PhD · Örebro University, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-19
Primary Completion
2022-05-01
Completion
2022-05-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04824599 on ClinicalTrials.gov