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Local Anesthetic

Intermittent Bolus vs Continuous Infusion for Postoperative Pain

Phase 4

Recruiting

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 post-op

Awards & highlights

Study Summary

This trial compares 2 methods of post-op pain relief for cardiac surgery. It evaluates opioid use, pain & ICU stay. It hypothesizes that one method may provide better relief. Findings may help decide best pain relief post-op for cardiac surgery.

Who is the study for?

This trial is for adults aged 18-90 undergoing non-emergency elective heart surgery that requires opening the chest (like bypass or valve replacements) and who will have a pain relief catheter placed before surgery. It's not for those with certain heart devices, cognitive issues, language barriers, opioid use before surgery, substance abuse history, or a BMI over 45.Check my eligibility

What is being tested?

The study compares two ways of managing pain after open-heart surgery: giving ropivacaine as an intermittent programmed bolus versus a continuous infusion through ESP catheters. The main focus is on how much opioid medication patients need after their operation. Pain levels and recovery factors like ICU stay are also tracked.See study design

What are the potential side effects?

While specific side effects aren't listed here, generally ropivacaine can cause low blood pressure, nausea, vomiting, numbness in parts of the body where it's applied and sometimes allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 post-op for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Opioid consumption

Secondary outcome measures

ICU length of stay

NRS Pain Scores (10)

Quality of Recovery 15 (QoR-15) score

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intermittent BolusExperimental Treatment1 Intervention

Will receive intermittent boluses of pain medication (30mL bolus of 0.2% ropivacaine every three hours) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision.

Group II: Continuous InfusionActive Control1 Intervention

Will receive a continuous infusion of pain medication (0.2% ropivacaine at a rate of 10mL per hour- 5mL per side per hour) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor

300 Previous Clinical Trials

2,099,759 Total Patients Enrolled

1 Trials studying Postoperative Pain

300 Patients Enrolled for Postoperative Pain

Avanos MedicalOTHER

8 Previous Clinical Trials

1,658 Total Patients Enrolled

Media Library

Ropivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05642416 — Phase 4

Postoperative Pain Research Study Groups: Continuous Infusion, Intermittent Bolus

Postoperative Pain Clinical Trial 2023: Ropivacaine Highlights & Side Effects. Trial Name: NCT05642416 — Phase 4

Ropivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05642416 — Phase 4

Frequently Asked Questions

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

Does this research project accept elderly individuals as participants?

"This medical experiment is looking for participants between 18 and 90 years of age."

Answered by AI

Has Intermittent Bolus been given the seal of approval by the FDA?

"Our group at Power has assigned Intermittent Bolus a score of 3 in terms of safety, since this therapy is already accepted and approved."

Answered by AI

May I participate in this research endeavor?

"To qualify for this clinical research, potential participants must have experienced postoperative pain and be between 18 to 90 years of age. The total number of individuals accepted into the trial is 240."

Answered by AI

How many participants are participating in this clinical experiment?

"Affirmative. Clinicaltrials.gov states that this clinical trial, which was initially uploaded on October 15th 2022, is currently accepting participants. The study requires the enrollment of 240 patients at a single medical site."

Answered by AI

Is this experiment still open for enrollment?

"Affirmative. According to clinicaltrials.gov, this trial is still recruiting patients who meet the criteria. It was initially posted on October 15th 2022 and was recently revised on November 30th 2022. A total of 240 individuals need to be recruited from one location for this study's success."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT

Patrick Forrest 2022. "Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05642416.