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CompletedNCT03480984Updated Apr 1, 2020

Continuous Versus Intermittent Bolus Infusion of Paravertebral Blocks for Thoracic Surgery

An interventional study of Programmed Intermittent Bolus and Continuous Infusion in Thoracic Diseases, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-01.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Thoracic Diseases

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In context

Thoracic Diseases

72 studies on the registry are indexed under Thoracic Diseases; 13 are open to participants now.

This study's enrollment of 50 is below the median of 65 across 52 interventional studies indexed under Thoracic Diseases.

Browse Thoracic Diseases studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Programmed Intermittent Bolus

    6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via an hourly programmed bolus

    Other: Programmed Intermittent Bolus

  • Active comparator
    Continuous Infusion

    6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via continuous infusion

    Other: Continuous Infusion

Interventions

  • OtherProgrammed Intermittent Bolus

    6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via an hourly programmed bolus

  • OtherContinuous Infusion

    6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via continuous infusion

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What researchers measure

Primary outcomes

  1. Opioid consumption 24 hours postoperatively

    morphine equivalents of opioids in mg will be obtained from medical record

    Time frame: first 24 hours postoperatively

Secondary outcomes

  1. Opioid consumption 48 hours postoperatively

    morphine equivalents of opioids in mg will be obtained from medical record

    Time frame: first 48 hours postoperatively

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Study locations

1 site
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
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References and documents

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Jan 2020, 23 months.

Of 27 interventional studies with no phase under Thoracic Diseases, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 42. This study's 23 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2018
First posted
Mar 29, 2018
StartActual
Feb 5, 2018
Primary completionActual
Jan 5, 2020
CompletionActual
Jan 31, 2020
Last update
Apr 1, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03480984
Lead sponsor
Mayo Clinic
Responsible party
Elird Bojaxhi, M.D. (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Mar 29, 2018
Start date
Feb 5, 2018
Primary completion
Jan 5, 2020
Completion
Jan 31, 2020
Last update
Apr 1, 2020

Study contacts

Elird Bojaxhi, MD
principal investigator · Mayo Clinic

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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