Cardiac Surgery, Sternotomy
Conditions
Keywords
ESP Block, PIF Block, Cardiac Surgery, Sternotomy
Brief summary
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.
Interventions
PROCEDUREESP block
peripheral nerve block
PROCEDUREPIF block
peripheral nerve block
PROCEDUREUltrasound
Ultrasound guidance
DRUGBupivacain
10-20 mL of 0.25% bupivacaine
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The anesthesiologist assessing the patient will be blinded
Intervention model description
Patients will be assigned randomly using a computer-generated table of numbers to one of the three groups: 1) ESP group, 2) PIF group, or 3) no block group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption during first 24 hours post-op | 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. |
| Opioid Consumption during first 48 hours post-op | 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. |
| Opioid Consumption during first 72 hours post-op | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Score (VAS) Pain Score post-op 24 hours | 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. |
| Visual Analogue Score (VAS) Pain Score post-op 48 hours | 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. |
| Visual Analogue Score (VAS) Pain Score post-op 72 hours | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAli Shariat, M.D.
Mount Sinai West and Morningside Hospitals
STUDY_DIRECTORHimani Bhatt, D.O.
Mount Sinai West and Morningside Hospitals
STUDY_DIRECTORShenghao Fang, M.D.
Mount Sinai West and Morningside Hospitals
Outcome results
None listed