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Nerve Blocks for Post-Surgical Pain After Cardiac Surgery
Phase < 1
Recruiting
Led By Ali Shariat, M.D.
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults 18-85 years old
Scheduled to undergo cardiac procedures involving sternotomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative 72 hours
Awards & highlights
Study Summary
This trial compares two nerve blocks to reduce post-surgical pain in 90 people aged 18-85 undergoing cardiac surgery. Pain scores & opioid consumption will be monitored. Risks include nervous & cardiac system toxicity.
Who is the study for?
This trial is for adults aged 18-85 who are scheduled for cardiac surgery involving a sternotomy. It's open to all genders. People can't join if they're in critical health (ASA class V), need urgent surgery, have allergies to local anesthesia, can't consent, or have a history of substance abuse or chronic opioid use.Check my eligibility
What is being tested?
The study compares the effectiveness of two pain control methods after heart surgery: ESP block and PIF block using ultrasound guidance and Bupivacain. Participants will be randomly assigned one of three different regimens at the start of their surgery.See study design
What are the potential side effects?
While side effects are not common, there's a risk that the local anesthetic could get absorbed into the body causing potential toxicity which might affect both the brain and heart.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 85 years old.
Select...
I am scheduled for heart surgery that involves opening my chest.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative 72 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Opioid Consumption during first 24 hours post-op
Opioid Consumption during first 48 hours post-op
Opioid Consumption during first 72 hours post-op
Secondary outcome measures
Visual Analogue Score (VAS) Pain Score post-op 24 hours
Visual Analogue Score (VAS) Pain Score post-op 48 hours
Visual Analogue Score (VAS) Pain Score post-op 72 hours
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: PIF groupExperimental Treatment3 Interventions
Patient will receive PIF block after intubation with ultrasound placed 1-2 cm lateral to the sternal border and the pectoralis major and external intercostal muscles are visualized at the level of ribs 3-4 where 10 mL of 0.25% bupivacaine will be injected on each side using a 21-gauge block needle.
Group II: ESP groupExperimental Treatment3 Interventions
Patient will receive ESP block with ultrasound guidance the transverse process of the vertebra at T7 is visualized and 20 mL of 0.25% bupivacaine will be injected between the transverse process and the erector spinae muscle on each side using a 21-gauge block needle.
Group III: No Block groupActive Control1 Intervention
Patient will not receive block.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ESP block
2019
Completed Phase 4
~690
Ultrasound
2013
Completed Phase 1
~1950
Bupivacain
2022
Completed Phase 4
~1610
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
861 Previous Clinical Trials
525,186 Total Patients Enrolled
Himani Bhatt, D.O.Study DirectorMount Sinai West and Morningside Hospitals
Shenghao Fang, M.D.Study DirectorMount Sinai West and Morningside Hospitals
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery urgently or as an emergency.I am allergic to or cannot have local anesthesia.My gender does not affect my eligibility.I am unable or unwilling to give consent for treatment.I am between 18 and 85 years old.I am scheduled for heart surgery that involves opening my chest.
Research Study Groups:
This trial has the following groups:- Group 1: ESP group
- Group 2: PIF group
- Group 3: No Block group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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