Serratus Plane Block for the Prevention of Chronic Pain After Breast Cancer Surgery
1 other identifier
interventional
110
0 countries
N/A
Brief Summary
This study compare the "Serratus block plane" (SPB) and the local infiltration of the tissue in the prevention of acute and chronic pain after breast cancer surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
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
First Submitted
Initial submission to the registry
June 30, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedFirst Posted
Study publicly available on registry
July 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedJuly 20, 2016
June 1, 2016
1.4 years
June 30, 2016
July 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative chronic pain assessed using the DN4 questionnaire
DN4 questionnaire
3 months postoperative
Secondary Outcomes (2)
postoperative acute pain
day 1, day 2, day 3 postoperative
morphine consumption
day 1, day 2, day 3 postoperative
Other Outcomes (2)
length of stay in the Postoperative Acute Care Unit
through study completion
length of stay in hospital
through study completion
Study Arms (2)
SPB
EXPERIMENTALSerratus Plane Bloc with Ropivacaine 2mg/ml (0,3ml/kg) and tissue infiltration with placebo made once, by the anesthetist in the operating theater before surgical incision
tissue infiltration
ACTIVE COMPARATORtissue infiltration with Ropivacaine 2mg/ml (0,3ml/kg) and Serratus Plane Bloc with placebo made once, by the anesthetist in the operating theater before surgical incision
Interventions
Eligibility Criteria
You may qualify if:
- Women scheduled for elective breast neoplasm surgery
- Of ASA classification 1, 2 or 3
- Patients who provide written informed consent
You may not qualify if:
- Minor patients
- Patients refusing to sign the consent
- Patients included in another protocol within 3 months
- Pregnant or lactating patients
- Patients with history of allergy to local anesthetics (Ropivacaine)
- Patients with contraindication to regional anesthesia (coagulopathy, local infection ...)
- Patients with history of prior breast surgery (excluding diagnostic biopsy)
- Patients with history of chronic pain
- Patients with a history of psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
PMID: 23923989BACKGROUNDAndreae MH, Andreae DA. Regional anaesthesia to prevent chronic pain after surgery: a Cochrane systematic review and meta-analysis. Br J Anaesth. 2013 Nov;111(5):711-20. doi: 10.1093/bja/aet213. Epub 2013 Jun 28.
PMID: 23811426BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Luc Van Obbergh, MD PhD
Erasme University Hospital
Central Study Contacts
Wendy Villareal Fernandez, MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 30, 2016
First Posted
July 20, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2017
Study Completion
March 1, 2018
Last Updated
July 20, 2016
Record last verified: 2016-06