Continuous Versus Intermittent Bolus Infusion of Paravertebral Blocks for Thoracic Surgery
A Comparison Between Continuous Versus Intermittent Bolus Infusion of Paravertebral Blocks for Thoracic Surgery: A Randomized Controlled Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
The researchers are trying to determine pain medication consumption in the first 24 hours after surgery in patients given the standard continuous infusion of local anesthetic versus patients given the same total dose via programmed intermittent dosing. Both groups will receive the option of patient controlled pain medication as well as the same dose of pre-programmed pain medication. The only difference is the rate of administration: continuous vs. hourly intervals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
Typical duration for not_applicable
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
February 1, 2018
CompletedStudy Start
First participant enrolled
February 5, 2018
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedApril 1, 2020
March 1, 2020
1.9 years
February 1, 2018
March 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Opioid consumption 24 hours postoperatively
morphine equivalents of opioids in mg will be obtained from medical record
first 24 hours postoperatively
Secondary Outcomes (1)
Opioid consumption 48 hours postoperatively
first 48 hours postoperatively
Study Arms (2)
Programmed Intermittent Bolus
ACTIVE COMPARATOR6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via an hourly programmed bolus
Continuous Infusion
ACTIVE COMPARATOR6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via continuous infusion
Interventions
6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via an hourly programmed bolus
6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via continuous infusion
Eligibility Criteria
You may qualify if:
- Documentation of planned thoracic surgery for which a paravertebral catheter is indicated based on surgeon request as well as appropriateness of location of surgical site.
- Ability for subject to comply with the requirements of the study.
You may not qualify if:
- Pregnancy.
- Coagulopathy at time of evaluation or surgery.
- Infection at the site of needle insertion.
- Allergy to local anesthetic.
- Patient refusal.
- Chronic opioid use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Jacksonville, Florida, 32224, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elird Bojaxhi, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Investigators will not have direct access to settings on the pump
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 1, 2018
First Posted
March 29, 2018
Study Start
February 5, 2018
Primary Completion
January 5, 2020
Study Completion
January 31, 2020
Last Updated
April 1, 2020
Record last verified: 2020-03