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OpenTrials
Completed

NCT Number: NCT03480984

Continuous Versus Intermittent Bolus Infusion of Paravertebral Blocks for Thoracic Surgery

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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Key information

Conditions

Thoracic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Programmed Intermittent Bolus

Other

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

Continuous infusion

Other

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

Primary outcomes

  1. Opioid consumption 24 hours postoperatively

    Time frame: first 24 hours postoperatively

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

Secondary outcomes

  1. Opioid consumption 48 hours postoperatively

    Time frame: first 48 hours postoperatively

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Comparison Between Continuous Versus Intermittent Bolus Infusion of Paravertebral Blocks for Thoracic Surgery: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 29, 2018
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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