- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04985500
ESP/PIF for Sternotomy
Erector Spinae Plane Block vs. Pecto-intercostal Fascial Plane Block vs. Control for Sternotomy: A Prospective Randomized Trial
This is a randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of two types of peripheral nerve blocks, specifically erector spinal plane (ESP) block and pecto-intercostal fascial (PIF) plane block.
90 subjects, from 18-85 years of age, undergoing cardiac surgery with median sternal incision will be enrolled at Mount Sinai Morningside Hospital Center. Study participation will last from the time of pre-operative evaluation to 72 hours after surgery. Subjects will be randomly assigned to receive 1 of the 3 different regimens at the beginning of surgery. Opioid consumption and pain scores after surgery will be evaluated. Though unlikely, risks include systemic absorption of local anesthetic, which can result in both central nervous system and cardiac toxicity.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Shenghao Fang, M.D.
- Phone Number: 434-326-8499
- Email: shenghao.fang@mountsinai.org
Study Contact Backup
- Name: Ali Shariat, M.D.
- Phone Number: 914-409-5023
- Email: alinima.shariat@mountsinai.org
Study Locations
-
-
New York
-
New York, New York, United States, 10025
- Recruiting
- Mount Sinai Morningside Hospital
-
Contact:
- Shenghao Fang, M.D.
- Phone Number: 434-326-8499
- Email: shenghao.fang@mountsinai.org
-
Contact:
- Ali Shariat, M.D.
- Phone Number: 914-409-5023
- Email: alinima.shariat@mountsinai.org
-
Principal Investigator:
- Ali Shariat, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults 18-85 years old
- Scheduled to undergo cardiac procedures involving sternotomy
- All genders
Exclusion Criteria:
- ASA class V
- Urgent or emergent surgery
- Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
- History of substance abuse or chronic opioid use
- Patient refusal or inability to consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ESP group
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.
|
peripheral nerve block
Other Names:
Ultrasound guidance
10-20 mL of 0.25% bupivacaine
|
Experimental: PIF group
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.
|
Ultrasound guidance
10-20 mL of 0.25% bupivacaine
peripheral nerve block
Other Names:
|
No Intervention: No Block group
Patient will not receive block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Consumption during first 24 hours post-op
Time Frame: Post-operative 24 hours
|
The amount of opioid consumption (in mg IV morphine equivalents) during the first 24 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
|
Post-operative 24 hours
|
Opioid Consumption during first 48 hours post-op
Time Frame: Post-operative 48 hours
|
The amount of opioid consumption (in mg IV morphine equivalents) during the first 48 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
|
Post-operative 48 hours
|
Opioid Consumption during first 72 hours post-op
Time Frame: Post-operative 72 hours
|
The amount of opioid consumption (in mg IV morphine equivalents) during the first 72 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
|
Post-operative 72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Score (VAS) Pain Score post-op 24 hours
Time Frame: Post-operative 24 hours
|
VAS Pain Score from 0-10, with higher score indicating more pain.
The average VAS pain scores during the first 24 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
|
Post-operative 24 hours
|
Visual Analogue Score (VAS) Pain Score post-op 48 hours
Time Frame: Post-operative 48 hours
|
VAS Pain Score from 0-10, with higher score indicating more pain.
The average VAS pain scores during the first 48 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
|
Post-operative 48 hours
|
Visual Analogue Score (VAS) Pain Score post-op 72 hours
Time Frame: Post-operative 72 hours
|
VAS Pain Score from 0-10, with higher score indicating more pain.
The average VAS pain scores during the first 72 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
|
Post-operative 72 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ali Shariat, M.D., Mount Sinai West and Morningside Hospitals
- Study Director: Himani Bhatt, D.O., Mount Sinai West and Morningside Hospitals
- Study Director: Shenghao Fang, M.D., Mount Sinai West and Morningside Hospitals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY-20-01473
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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