Ropivacaine 0,2% Plus Dexamethasone Versus Ropivacaine 0,2% Plus Placebo in Modified Pectoral Block
1 other identifier
interventional
60
1 country
1
Brief Summary
To find out if dexamethasone used as adjuvant to ropivacaine, a long-lasting local anesthetic, prolongs the duration of modified pectoral nerve block in women undergoing breast surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2019
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
First Submitted
Initial submission to the registry
October 1, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 12, 2020
March 1, 2020
1.9 years
October 1, 2018
March 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
morphine consumption in the first 72 hours
every participants receives a morphine pump (PCA) to exactly measure opioid-consumption
72 hours
Secondary Outcomes (1)
VAS-scores in the first 72 hours
72 hours
Study Arms (2)
ropivacaine + dexamethasone
ACTIVE COMPARATOREvery participant receives general anesthesia and a modified pectoral nerve block for breast surgery. Participants of this arm receive single-shot ropivacaine (0,2%, 30ml) plus 2ml dexamethasone (8mg).
ropivacaine + placebo
PLACEBO COMPARATOREvery participant receives general anesthesia and a modified pectoral nerve block for breast surgery. Participants of this arm receive single-shot ropivacaine (0,2%, 30ml) plus 2ml placebo (NaCl 0,9%).
Interventions
modified pectoralis block for breast surgery with ropivacaine combined with dexamethasone 8mg.
modified pectoralis block for breast surgery with ropivacaine combined with placebo (NaCl 0,9%).
30ml (=60mg) for modified pectoralis block (thoracic regional fascial plane block)
Eligibility Criteria
You may qualify if:
- female gender
- a American Society of Anesthesiologists (ASA) score of 1 or 2
- weight: body mass index (BMI) 18 - 35 kg/m2
- informed consent
- elective, unilaterale breast surgery
You may not qualify if:
- bleeding disorders
- any known allergy to the medication
- diabetes mellitus
- any disease that leads to alterations in the corticosteroid physiology
- drug-dependency
- BMI \<18 or \> 35
- systemic infections
- psychiatric diseases, that are associated with an alteration in the perception of pain
- tumor spread at the site of injection
- inflammation at the site of injection
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Innsbruck
Innsbruck, Tyrol, 6020, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karl Lindner, Prof.Dr.
Department of Anesthesia and Intensive Care
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- 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
October 1, 2018
First Posted
October 9, 2018
Study Start
February 1, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
March 12, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share