Intravenous(IV) vs. Erector Spinae Plane Blocks in Cardiac Surgery

NCT ID: NCT04995497

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-15
• Study Completion Date: 2023-04-30

Brief Summary

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.

Detailed Description

Post-operative pain is a significant issue following open heart surgeries and poorly controlled pain can result in significant cardiorespiratory morbidity. Many patients suffer pain both at rest (49%) and on movement (62%) following open heart surgeries via sternotomy and adequate pain management requires closer re-assessment and treatment. The intensity of pain is noted to be higher in the first 48 hours post surgery and hence modalities to control pain may make the greatest difference in the first 2 days after surgery.

Enhanced recovery pathways utilizing multimodal analgesia have shown significant analgesic and opioid sparing benefit while minimizing ICU and length of hospital stays. Some multimodal regimens have also incorporated regional blocks but the optimal analgesic regimen remains elusive. The ESP block has been hypothesized to provide truncal anesthesia by spread of local anesthetic into the paravertebral space, but recent studies contest this idea. Bilateral paravertebral blocks can result in higher than acceptable levels of local anesthetic in both cardiac and non-cardiac surgical patients and this may be true following bilateral erector spinae plane (ESP) as well. Hence, the pharmacokinetic profile of administered local anesthetics is necessary given the lack of information about the local anesthetic systemic levels following bilateral ESP.

Conditions

Erector Spinae Plane Block; Pain Control; Post-Operative Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erector Spinae Plane Block-Administration of Lidocaine

Bilateral ultrasound guided erector spinae plane catheter placement for the administration of lidocaine. Dose will be 2 mg/kg ideal body weight. Bolus will be divided equally between the two ESP catheters. This is followed by lidocaine infusion via ESP catheter at 2 mg/kg/hr for 48 hours after catheter placement.

Group Type: EXPERIMENTAL

Administration of Lidocaine Post Cardiac Surgery via ESP Catheter

Intervention Type: DRUG

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

Intravenous-Administration of Lidocaine

Subject will receive a bolus of lidocaine at 2 mg/kg ideal body weight. This is followed by lidocaine infusion via intravenous route at 2 mg/kg/hr for 48 hours.

Group Type: ACTIVE_COMPARATOR

Intravenous Administration of Lidocaine Post Cardiac Surgery

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Pain control post cardiac surgery; Pain control post cardiac surgery

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 50
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Archit Sharma

OTHER

Sponsor Role: lead

Responsible Party

Archit Sharma

Clinical Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Archit Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

202009510

Identifier Type: -

Identifier Source: org_study_id