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Clinical trial

IV vs. Erector Spinae Plane Blocks-Cardiac Surgery

ID
Name
202009510
Description
Interfascial plane blocks have been developed for analgesia, among which the erector spinae plane (ESP) has gained popularity. The ESP block has been hypothesized to provide truncal analgesia by spread of local anesthetic into the paravertebral space. Recent studies have contested this idea showing unreliability in the spread of the local anesthetic into the paravertebral space.
Trial arms
Trial start
2021-08-15
Estimated PCD
2023-04-07
Trial end
2023-04-30
Status
Completed
Phase
Early phase I
Treatment
Intravenous Administration of Lidocaine Post Cardiac Surgery
Lidocaine will be administered via intravenously. Initial dose will be at 2 mg/kg ideal body weight followed by dosing at 2 mg/kg/hr for 48 hours
Arms:
Intravenous-Administration of Lidocaine
Other names:
Pain control post cardiac surgery
Administration of Lidocaine Post Cardiac Surgery via ESP Catheter
Lidocaine will be administered via ESP catheter. Initial dose will be at 2 mg/kg ideal body weight split between two catheters followed by dosing at 2 mg/kg/hr for 48 hours
Arms:
Erector Spinae Plane Block-Administration of Lidocaine
Other names:
Pain control post cardiac surgery
Size
70
Primary endpoint
Quantitate and report changes in pain scores reported by subject
First 2 days post surgical intervention
Quantitate the amount of opioid medication required to provide pain relief
First 2 days post surgical intervention
Eligibility criteria
Inclusion Criteria: * Undergoing elective cardiac surgery for coronary artery bypass graft (CABG) or valve surgery via sternotomy. * English speaking Exclusion Criteria: * Emergency surgery * Allergy to medications (ie lidocaine) * BMI less than 20 or greater than 35 * Major liver or kidney dysfunction or other pre-existing major organ dysfunction * Revision cardiac surgery * Surgery via thoracotomy * Off-pump coronary artery bypass * Narcotic dependent (Opioid intake morphine equivalents greater than 10mg/day for more than 3 months * Chronic pain (ie fibromyalgia) * Significant central nervous system or respiratory disease * Hematological disorders or de-ranged coagulation parameters * Psychiatric illness that impedes subject from providing informed consent * Pre-operative neurological deficits * Language barrier * Inability to provide informed consent * Prisoner status * Pregnancy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}
Updated at
2024-02-06

1 organization

1 product

4 indications

Organization
Archit Sharma
Product
Lidocaine
Indication
Erector Spinae Plane Block
Indication
Pain Management
Indication
Post-Operative Pain
Indication
Chronic