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

Women's College Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Anesthesia

Treatments: Procedure: Serratus Block; Other: sterile saline; Drug: epinephrine; Procedure: Placebo Block; Drug: ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02453516

2014-0051-E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Serratus Block Group

Experimental group

Description:

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

Treatment:

Drug: ropivacaine

Drug: epinephrine

Procedure: Serratus Block

Placebo Block - Control Group

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Placebo Block

Other: sterile saline