The Effect of the Serratus Block on Pain Control After Breast Surgery

NCT ID: NCT02453516

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-29
• Study Completion Date: 2019-12-11

Brief Summary

Surgery for breast cancer is associated with significant pain. The serratus nerve block targets the interfascial plane either below or above the serratus muscle, blocking thereby the lateral cutaneous branches of the intercostal nerves. The purpose of this randomized controlled double-blinded study is to see whether the addition of a serratus nerve block to a general anesthesia results in a better postoperative pain control in patients undergoing surgery for breast cancer.

Detailed Description

The prevalence of severe acute postoperative pain after breast surgery is high. Regional anesthesia has the potential to provide superior pain relief with fewer side effects compared to standard systemic opioid therapy. The search for a regional anesthesia technique for breast surgery has been ongoing as this technique needs to be time efficient, relatively risk-free and also practicable in an out-patient setting. The serratus block is a promising technique that may combine these advantages.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Serratus Block Group

Patients will receive a preoperative ultrasound-guided serratus block with 0.4ml/kg (max.30ml) of ropivacaine 0.5% with 1:4000,000 epinephrine injected between the serratus anterior (superficial) and external intercostal (deep) muscles followed by subsequent general anesthesia

Group Type: EXPERIMENTAL

Serratus Block

Intervention Type: PROCEDURE

Ultrasound-guided nerve block using ropivacaine 0.5% (0.4ml/kg) injected between the serratus anterior and external intercostal muscles

ropivacaine

Intervention Type: DRUG

Drug indicated for regional anesthesia

epinephrine

Intervention Type: DRUG

Drug indicated to prolong the action of regional anesthesia

Placebo Block - Control Group

Patients will receive a preoperative placebo injection with a subcutaneous injection of 1ml normal sterile saline solution in the midaxillary line and the ultrasound probe will be used to simulate the pressure and block duration associated with the serratus block. These patients will then receive general anesthesia.

Group Type: PLACEBO_COMPARATOR

Placebo Block

Intervention Type: PROCEDURE

Subcutaneous injection of 1ml sterile normal saline solution in the midaxillary line

sterile saline

Intervention Type: OTHER

Neutral injection (no drug involved)

Interventions

Serratus Block

Ultrasound-guided nerve block using ropivacaine 0.5% (0.4ml/kg) injected between the serratus anterior and external intercostal muscles

Intervention Type: PROCEDURE

Placebo Block

Subcutaneous injection of 1ml sterile normal saline solution in the midaxillary line

Intervention Type: PROCEDURE

ropivacaine

Drug indicated for regional anesthesia

Intervention Type: DRUG

epinephrine

Drug indicated to prolong the action of regional anesthesia

Intervention Type: DRUG

sterile saline

Neutral injection (no drug involved)

Intervention Type: OTHER

Other Intervention Names

Control Group - Placebo Comparator; Naropin HCL; Adrenaline Chloride; Sodium Chloride

Eligibility Criteria

Inclusion Criteria

• ASA I to III (American Society of Anesthesiologists Physical Status Classification System)
• undergoing unilateral primary or secondary breast surgery for cancer, specifically: lumpectomies with sentinel node biopsy or partial mastectomies or simple mastectomies, with or without sentinel node biopsy
• 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 anesthestic
• chronic pain and/or chronic use of opioids with a daily use of over 30mg 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 the injection site
• pregnancy
• BMI >35
• complication or adverse events unrelated to the study intervention that precludes evaluation of the primary and secondary outcomes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Brull, MD FRCP

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Locations

Women's College Hospital

Toronto, Ontario, Canada

Countries

Canada

References

Abdallah FW, Patel V, Madjdpour C, Cil T, Brull R. Quality of recovery scores in deep serratus anterior plane block vs. sham block in ambulatory breast cancer surgery: a randomised controlled trial. Anaesthesia. 2021 Sep;76(9):1190-1197. doi: 10.1111/anae.15373. Epub 2021 Jan 25.

Reference Type: DERIVED

PMID: 33492696 (View on PubMed)

Other Identifiers

2014-0051-E

Identifier Type: -

Identifier Source: org_study_id