The Effect of the Serratus Block on Pain Control After Breast Surgery
- Conditions
- Anesthesia
- Interventions
- Procedure: Serratus BlockProcedure: Placebo BlockOther: sterile saline
- Registration Number
- NCT02453516
- Lead Sponsor
- Women's College Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Serratus Block Group Serratus Block 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 Placebo Block - Control Group Placebo Block 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. Placebo Block - Control Group sterile saline 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. Serratus Block Group ropivacaine 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 Serratus Block Group epinephrine 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
- Primary Outcome Measures
Name Time Method Post-operative pain scores 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.. 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.
- Secondary Outcome Measures
Name Time Method 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 Admission to phase I recovery (PACU) until discharge from phase II recovery, total time is estimated up to 6 hours, Duration of stay in PACU and in surgical day care
Opioid side-effects End of surgical procedure to 7 days following surgery Opioid-related side effects (nausea, vomiting, pruritis)
Block-related side-effects Completion of block to 3 months postoperatively Presence/absence of block-related side effects such as bruising, infection, systemic toxicity, persistent numbness or shoulder weakness
Satisfaction with analgesia End of surgical procedure to 3 months postoperatively Scale of 0-10 (0=Not Satisfied, 10=Very Satisfied)
Quality of recovery score (QoR) Discharge from hospital until 24 hours post-op Completion of questionnaire (QoR) done by patient.
Pain assessment Assessment to be done again @ 6 weeks and 3 months postoperatively. Simple question requiring a yes or no response. Persistent postsurgical pain
Trial Locations
- Locations (1)
Women's College Hospital
🇨🇦Toronto, Ontario, Canada