Continuous Versus Intermittent Bolus Infusion of Paravertebral Blocks for Thoracic Surgery

Thoracic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480984
• Other study ID #: 17-009991
• Status: Completed
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 31, 2020
• Est. primary completion date: January 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Diseases

Intervention

Other:
• Programmed Intermittent Bolus
6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via an hourly programmed bolus
• Continuous Infusion
6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via continuous infusion

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption 24 hours postoperatively	morphine equivalents of opioids in mg will be obtained from medical record	first 24 hours postoperatively
Secondary	Opioid consumption 48 hours postoperatively	morphine equivalents of opioids in mg will be obtained from medical record	first 48 hours postoperatively

External Links

•   Mayo Clinic Clinical Trials