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

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Diseases
• Intervention / Treatment: Other: Programmed Intermittent Bolus; Other: Continuous Infusion

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via an hourly programmed bolus
Active Comparator: Continuous Infusion; 6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via continuous infusion	Other: Continuous Infusion; 6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via continuous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption 24 hours postoperatively	morphine equivalents of opioids in mg will be obtained from medical record	first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption 48 hours postoperatively	morphine equivalents of opioids in mg will be obtained from medical record	first 48 hours postoperatively

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Elird Bojaxhi, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): January 5, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Thoracic Diseases
• Other Study ID Numbers: 17-009991

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No