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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of The Serratus Block on Analgesia After Breast Surgery A Randomized Controlled Double-Blinded Study

Conditions
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Anesthesia

Intervention / Treatment
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* Procedure: Serratus Block
* Procedure: Placebo Block
* Drug: ropivacaine
* Drug: epinephrine
* Other: sterile saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serratus Block Group<br>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 | Procedure: Serratus Block<br>* Ultrasound-guided nerve block using ropivacaine 0.5% (0.4ml/kg) injected between the serratus anterior and external intercostal muscles<br>Drug: ropivacaine<br>* Drug indicated for regional anesthesia<br>* Other names: Naropin HCL;Drug: epinephrine<br>* Drug indicated to prolong the action of regional anesthesia<br>* Other names: Adrenaline Chloride;|
| Placebo Comparator: Placebo Block - Control Group<br>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. | Procedure: Placebo Block<br>* Subcutaneous injection of 1ml sterile normal saline solution in the midaxillary line<br>* Other names: Control Group - Placebo Comparator;Other: sterile saline<br>* Neutral injection (no drug involved)<br>* Other names: Sodium Chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain scores | The patient's level of pain in the postoperative period will be evaluated by the use of a 100mm Visual Analogue Scale (VAS). The mean of these scores at the 3 different time points will be calculated. | Scores collected @ 3 different time points: admission to phase I recovery (PACU), admission to phase II recovery (day surgery unit), and discharge from day surgery unit The total time time is estimated to be up to 6 hours.. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative opioid consumption |  | Duration of actual surgical procedure | 
| Post-operative opioid consumption |  | End of surgical procedure until 7 days after surgery | 
| Duration phase I and phase II recovery | Duration of stay in PACU and in surgical day care | Admission to phase I recovery (PACU) until discharge from phase II recovery, total time is estimated up to 6 hours, | 
| Opioid side-effects | Opioid-related side effects (nausea, vomiting, pruritis) | End of surgical procedure to 7 days following surgery | 
| Block-related side-effects | Presence/absence of block-related side effects such as bruising, infection, systemic toxicity, persistent numbness or shoulder weakness | Completion of block to 3 months postoperatively | 
| Satisfaction with analgesia | Scale of 0-10 (0=Not Satisfied, 10=Very Satisfied) | End of surgical procedure to 3 months postoperatively | 
| Quality of recovery score (QoR) | Completion of questionnaire (QoR) done by patient. | Discharge from hospital until 24 hours post-op | 
| Pain assessment | Persistent postsurgical pain | Assessment to be done again @ 6 weeks and 3 months postoperatively. Simple question requiring a yes or no response. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serratus Block, Breast Surgery