Serratus and Parasternal Infrapectoral Block for Breast Surgery.

NCT03708302 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-03-07

No results posted yet for this study

Summary

Effective pain control is important following breast surgery as it improves quality of recovery, decreases the risk of chronic pain development and reduction of overall health care cost. Current strategies of pain management for breast surgery include use of opioid medication or addition of regional anesthesia along with general anesthesia. Serratus block and parasternal infrapectoral blocks are newly developed fascial plane blocks that are technically easy to perform, effective and safe based on our daily clinical practice and published evidence. We are comparing the addition of serratus and parasternal infrapectoral nerve block with general anesthesia to a combination of placebo and general anesthesia for breast reduction surgery. We propose that this would result in an improved efficiency resulting in early hospital discharge and improve quality of patient care, following breast reduction surgery.

Conditions

  • Breast Pain
  • Post-Op Complication

Interventions

PROCEDURE

Unilateral serratus plane block

Ultrasound guided unilateral serratus plane block will be performed at the level of 4th rib in anterior axillary line. After skin infiltration with 1% lidocaine, 80mm 22G block needle will be inserted at the caudal aspect of the ultrasound probe and advanced in-plane to target the fascial plane directly below the serratus muscle. Once the tip is verified in the correct position, 20mls of 0.5% ropivacaine will be injected in the plane in 5 mls aliquot after aspiration. Ultrasound guided unilateral parasternal infrapectoral plane block will be performed at the level of 4th rib, lateral to the sternum. After skin infiltration with 1% lidocaine, 80mm 22G block needle will be inserted at the caudal aspect of the ultrasound probe and advanced in-plane to target the fascial plane directly below the pectoralis major muscle. Once the tip is verified in the correct position, 20mls of 0.5% ropivacaine will be injected in the plane slowly in 5 ml aliquots after aspiration.

PROCEDURE

Unilateral parasternal infrapectoral block

Ultrasound guided unilateral serratus plane block will be performed at the level of 4th rib in anterior axillary line. After skin infiltration with 1% lidocaine, 80mm 22G block needle will be inserted at the caudal aspect of the ultrasound probe and advanced in-plane to target the fascial plane directly below the serratus muscle. Once the tip is verified in the correct position, 20 mls of 0.9% saline will be injected in the plane in 5 mls aliquot after aspiration. Ultrasound guided unilateral parasternal infrapectoral plane block will be performed at the level of 4th rib, lateral to the sterum. After skin infiltration with 1% lidocaine, 80mm 22G block needle will be inserted at the caudal aspect of the ultrasound probe and advanced in-plane to target the fascial plane directly below the pectoralis major muscle. Once the tip is verified in the correct position, 20 mls of 0.9% saline will be injected in the plane slowly in 5 ml aliquots after aspiration.

Sponsors & Collaborators

  • Western University, Canada

    lead OTHER

Principal Investigators

  • Abhijit Biswas, MD · London Health Sciences Center, Western University, London. Ontario. Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2024-12-31
Completion
2025-06-30

Countries

  • Canada

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 NCT03708302 on ClinicalTrials.gov