The Effect of the Serratus Block on Pain Control After Breast Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Procedure: Serratus Block
Ultrasound-guided nerve block using ropivacaine 0.5% (0.4ml/kg) injected between the serratus anterior and external intercostal muscles
Drug: ropivacaine
Drug indicated for regional anesthesia
Other Names:
Drug: epinephrine
Drug indicated to prolong the action of regional anesthesia
Other Names:
|
| Placebo Comparator: 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. |
Procedure: Placebo Block
Subcutaneous injection of 1ml sterile normal saline solution in the midaxillary line
Other Names:
Other: sterile saline
Neutral injection (no drug involved)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Women's College Hospital | Toronto | Ontario | Canada | M5S 1B2 |
Sponsors and Collaborators
- Women's College Hospital
Investigators
- Principal Investigator: Richard Brull, MD FRCP, Women's College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2014-0051-E