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Procedure

Paravertebral Block for Post Cardiac Surgery Pain

N/A

Recruiting

Led By Terri Sun, M.D.

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

3 or more major procedures

Procedures requiring deep hypothermic circulatory arrest (DHCA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 4 hours for the first 24 hours then every 8 hours until the 48 hour mark following surgery

Awards & highlights

Study Summary

This trial will compare single-shot paravertebral nerve blocks to sham blocks to see if they can reduce pain and improve quality of recovery after cardiac surgery.

Who is the study for?

This trial is for adults over 19 years old scheduled for elective cardiac surgery who are English-speaking, at high risk (Euroscore II >=8%), and expected to need post-op ventilation for more than a day. It's not for those with chronic pain or opioid use, psychiatric disorders, severe organ failure, allergies to study meds, extreme weights, or certain blood conditions.Check my eligibility

What is being tested?

The study tests if a paravertebral block using ropivacaine before chest opening can improve recovery quality after heart surgery compared to sham blocks with saline. It looks at recovery scores after 24 hours and also examines pain levels, opioid needs, respiratory function, and sleep within the first two days.See study design

What are the potential side effects?

Possible side effects include discomfort at injection site, potential nerve damage from the block procedure itself. Ropivacaine may cause low blood pressure, nausea or vomiting; allergic reactions are possible but rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had 3 or more major surgeries.

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I require a procedure involving cooling and stopping my blood circulation.

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I expect to need help breathing for more than a day after surgery.

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I speak English.

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I am scheduled for heart surgery that involves opening my chest.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 4 hours for the first 24 hours then every 8 hours until the 48 hour mark following surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 4 hours for the first 24 hours then every 8 hours until the 48 hour mark following surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 4 hours for the first 24 hours then every 8 hours until the 48 hour mark following surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Initial Quality of Recover-15 (QoR-15) score

Secondary outcome measures

Cardiac Surgery Intensive Care unit length of stay

Duration of post-operative mechanical ventilation

Hospital length of stay

+9 more

Side effects data

From 2014 Phase 4 trial • 40 Patients • NCT01602692

40%

Nausea

10%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Tumescent Solution With Dilute Epinephrine

Tumescent Solution With Dilute Lidocaine and Epinephrine

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention GroupExperimental Treatment1 Intervention

Bilateral, single level, paravertebral blockade with 0.25% ropivicaine

Group II: Control GroupPlacebo Group1 Intervention

Bilateral, single level, subcutaneous sham block with normal saline

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian Anesthesiologists' SocietyOTHER

18 Previous Clinical Trials

2,784 Total Patients Enrolled

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,466,894 Total Patients Enrolled

6 Trials studying Postoperative Pain

1,132 Patients Enrolled for Postoperative Pain

Providence Health & ServicesOTHER

117 Previous Clinical Trials

822,311 Total Patients Enrolled

1 Trials studying Postoperative Pain

155 Patients Enrolled for Postoperative Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current vacancies in this research project?

"According to clinicaltrials.gov, this particular trial has ceased recruitment efforts; the initial post was made on September 1st 2023 and last revised August 18th 2023. However, 863 other medical research projects are still searching for candidates at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Paravertebral Block for Improvement of Quality of Recovery Following Cardiac Surgery

Terri Sun 2023. "Paravertebral Block for Improvement of Quality of Recovery Following Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06008821.