Serratus and Parasternal Infrapectoral Block for Breast Surgery.

NCT03708302 | Recruiting

• 1 other identifier: 112488
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to hospital discharge.

  Comparing time to hospital discharge; the total time being 'admission to postoperative Care Unit after surgery till discharge home.' this will be measured in minutes

  24 hours postoperative period

Secondary Outcomes (6)

• post operative pain score

  48 hours

• Cumulative Opioid consumption (in Intravenous Morphine equivalent).

  48 hours

• Duration of Hospital stay in minutes.

  24 hours

• Opioid-related side effects requiring treatment.

  48 hours

• Presence/absence of block-related side effects.

  48 hours

Study Arms (2)

Study Group

ACTIVE COMPARATOR

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

Procedure: Unilateral serratus plane block; Procedure: Unilateral parasternal infrapectoral block

Control Group

SHAM COMPARATOR

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

Procedure: Unilateral serratus plane block; Procedure: Unilateral parasternal infrapectoral block

Interventions

Unilateral serratus plane block PROCEDURE

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.

Control Group; Study Group

Unilateral parasternal infrapectoral block PROCEDURE

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.

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: The study is based on female patients coming for breast reduction surgery.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

St. Joseph's Hospital

London, Ontario, N6A4V2, Canada

RECRUITING

Related Publications (34)

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  PMID: 29794944 RESULT

• Biswas A, Castanov V, Li Z, Perlas A, Kruisselbrink R, Agur A, Chan V. Serratus Plane Block: A Cadaveric Study to Evaluate Optimal Injectate Spread. Reg Anesth Pain Med. 2018 Nov;43(8):854-858. doi: 10.1097/AAP.0000000000000848.

  PMID: 30063656 RESULT

MeSH Terms

Conditions

Mastodynia; Postoperative Complications

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Abhijit Biswas, MD

  London Health Sciences Center, Western University, London. Ontario. Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abhijit Biswas, MD

CONTACT

+14168301696; abhijit.biswas@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 17, 2018
• Study Start: July 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)