Cardiac Surgery Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai Morningside Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid Consumption during first 24 hours post-op | 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 | |
Primary | Opioid Consumption during first 48 hours post-op | 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 | |
Primary | Opioid Consumption during first 72 hours post-op | 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 | Visual Analogue Score (VAS) Pain Score post-op 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 | |
Secondary | Visual Analogue Score (VAS) Pain Score post-op 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 | |
Secondary | Visual Analogue Score (VAS) Pain Score post-op 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 |
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