Back to resultsContinuous Versus Intermittent Bolus Infusion of Paravertebral Blocks for Thoracic Surgery
Primary Purpose
Thoracic Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Programmed Intermittent Bolus
Continuous Infusion
Sponsored by
About this trial
This is an interventional other trial for Thoracic Diseases
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Pregnancy.
- Coagulopathy at time of evaluation or surgery.
- Infection at the site of needle insertion.
- Allergy to local anesthetic.
- Patient refusal.
- Chronic opioid use
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Programmed Intermittent Bolus
Continuous Infusion
Arm Description
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
Outcomes
Primary Outcome Measures
Opioid consumption 24 hours postoperatively
morphine equivalents of opioids in mg will be obtained from medical record
Secondary Outcome Measures
Opioid consumption 48 hours postoperatively
morphine equivalents of opioids in mg will be obtained from medical record
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03480984
Brief Title
Continuous Versus Intermittent Bolus Infusion of Paravertebral Blocks for Thoracic Surgery
Official Title
A Comparison Between Continuous Versus Intermittent Bolus Infusion of Paravertebral Blocks for Thoracic Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
January 5, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Investigators will not have direct access to settings on the pump
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Programmed Intermittent Bolus
Arm Type
Active Comparator
Arm Description
6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via an hourly programmed bolus
Arm Title
Continuous Infusion
Arm Type
Active Comparator
Arm Description
6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via continuous infusion
Intervention Type
Other
Intervention Name(s)
Programmed Intermittent Bolus
Intervention Description
6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via an hourly programmed bolus
Intervention Type
Other
Intervention Name(s)
Continuous Infusion
Intervention Description
6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via continuous infusion
Primary Outcome Measure Information:
Title
Opioid consumption 24 hours postoperatively
Description
morphine equivalents of opioids in mg will be obtained from medical record
Time Frame
first 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Opioid consumption 48 hours postoperatively
Description
morphine equivalents of opioids in mg will be obtained from medical record
Time Frame
first 48 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Pregnancy.
Coagulopathy at time of evaluation or surgery.
Infection at the site of needle insertion.
Allergy to local anesthetic.
Patient refusal.
Chronic opioid use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elird Bojaxhi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Continuous Versus Intermittent Bolus Infusion of Paravertebral Blocks for Thoracic Surgery
We'll reach out to this number within 24 hrs