ESP/PIF for Sternotomy
- Conditions
- Cardiac SurgerySternotomy
- Interventions
- Registration Number
- NCT04985500
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 225
- Adults 18-85 years old
- Scheduled to undergo cardiac procedures involving sternotomy
- All genders
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description ESP group Bupivacain 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. ESP group ESP block 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. PIF group Ultrasound 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. PIF group PIF block 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. ESP group Ultrasound 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. PIF group Bupivacain 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.
- Primary Outcome Measures
Name Time Method 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 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 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Mount Sinai Morningside Hospital
🇺🇸New York, New York, United States