The Effect of the Serratus Block on Pain Control After Breast Surgery
The Effect of The Serratus Block on Analgesia After Breast Surgery A Randomized Controlled Double-Blinded Study
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2014
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 29, 2014
CompletedFirst Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
May 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2019
CompletedJanuary 13, 2020
January 1, 2020
4.9 years
May 13, 2015
January 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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,
Opioid side-effects
End of surgical procedure to 7 days following surgery
Block-related side-effects
Completion of block to 3 months postoperatively
- +3 more secondary outcomes
Study Arms (2)
Serratus Block Group
EXPERIMENTALPatients 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 COMPARATORPatients 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.
Interventions
Ultrasound-guided nerve block using ropivacaine 0.5% (0.4ml/kg) injected between the serratus anterior and external intercostal muscles
Subcutaneous injection of 1ml sterile normal saline solution in the midaxillary line
Drug indicated to prolong the action of regional anesthesia
Neutral injection (no drug involved)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women's College Hospital
Toronto, Ontario, M5S 1B2, Canada
Related Publications (1)
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.
PMID: 33492696DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Brull, MD FRCP
Women's College Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2015
First Posted
May 25, 2015
Study Start
October 29, 2014
Primary Completion
September 11, 2019
Study Completion
December 11, 2019
Last Updated
January 13, 2020
Record last verified: 2020-01