Recruiting

Serratus & Parasternal

Sponsor:

Western University, Canada

Code:

NCT03708302

Conditions

Breast Pain

Post-Op Complication

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Unilateral serratus plane block

Unilateral parasternal infrapectoral block

Study Details

Brief 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

Study ID

NCT03708302

Start date

Jul 1, 2019

Status verified date

Mar, 2024

Completion date

Jun, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • women aged 18-80 years
  • ASA I to III (American Society of Anesthesiologists Physical Status Classification System)
  • Undergoing unilateral oncoplastic breast reduction mammoplasty, simple mastectomy surgery, or lumpectomy at St. Joseph's Hospital.
  • Day surgery procedures

Exclusion Criteria:

  • Inability to understand or to provide consent
  • Inability or unwillingness to comply with required follow-up assessments
  • Psychiatric disorder affecting patient assessment
  • Contraindication to regional anesthesia, e.g. coagulopathy
  • Allergy to local anesthetic
  • Chronic pain and/or chronic use of opioids with a daily use of over 30 mg oxycodone or equivalent per day
  • Contraindication to a component of multimodal analgesia
  • Preexisting neuropathy with motor or sensory deficits in the area of the anterolateral chest wall
  • Infection near injection site
  • Pregnancy
  • BMI>40
  • Complication or adverse events unrelated to the study intervention that precludes evaluation of the primary and secondary outcomes.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Study Group

Ultrasound guided unilateral serratus plane block and unilateral parasternal infrapectoral block with 0.5% ropivacaine.

sham comparator: Control Group

Ultrasound guided unilateral serratus plane block and unilateral parasternal infrapectoral block with 0.9% saline.

Interventions

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.

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.

Primary outcome measure

  • Time to hospital discharge. [ Time Frame: 24 hours postoperative period ]

Central Contacts and Locations

Central contacts

Abhijit Biswas, MD

+14168301696abhijit.biswas@lhsc.on.ca

Locations

St. Joseph's Hospital

Recruiting

London, Ontario, Canada, N6A4V2

Contacts

Abhijit Biswas, MD

+1 4168301696abhijit.biswas@lhsc.on.ca

Principal Investigator:

Abhijit Biswas, MD

More Information

Sponsor

Western University, Canada

Last update posted

Mar 7, 2024

Last verified

Mar, 2024

Keywords

  • breast surgery
  • serratus plane block
  • parasternal infrapectoral block
  • simple mastectomy
  • oncoplastic reduction mammoplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2024-03-07.