Clinical trial NCT02453516: The Effect of the Serratus Block on Pain Control After Breast Surgery
Official title: The Effect of The Serratus Block on Analgesia After Breast Surgery A Randomized Controlled Double-Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Anesthesia
Keywords: Serratus Block
Breast Surgery
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2015-05-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Post-operative pain scores
timeFrame: 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 outcomes:
measure: Intraoperative opioid consumption
timeFrame: Duration of actual surgical procedure
measure: Post-operative opioid consumption
timeFrame: End of surgical procedure until 7 days after surgery
measure: Duration phase I and phase II recovery
timeFrame: Admission to phase I recovery (PACU) until discharge from phase II recovery, total time is estimated up to 6 hours,
measure: Opioid side-effects
timeFrame: End of surgical procedure to 7 days following surgery
measure: Block-related side-effects
timeFrame: Completion of block to 3 months postoperatively
measure: Satisfaction with analgesia
timeFrame: End of surgical procedure to 3 months postoperatively
measure: Quality of recovery score (QoR)
timeFrame: Discharge from hospital until 24 hours post-op
measure: Pain assessment
timeFrame: Assessment to be done again @ 6 weeks and 3 months postoperatively. Simple question requiring a yes or no response.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Richard Brull, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.