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

IV vs. Erector Spinae Plane Blocks-Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Pain Control; Erector Spinae Plane Block; Post-Operative Pain, Chronic
• Intervention / Treatment: Drug: Administration of Lidocaine Post Cardiac Surgery via ESP Catheter; Drug: Intravenous Administration of Lidocaine Post Cardiac Surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Archit Sharma, MD; Phone Number: (319) 384-7911; Email: archit-sharma@uiowa.edu
• Study Contact Backup: Name: Rakesh Sondekoppam Vijayashankar, MD; Phone Number: (319) 356-2633; Email: rakesh-sondekoppam@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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; Other Names: Pain control post cardiac surgery
Active Comparator: Intravenous-Administration of Lidocaine; Sham block procedure (catheter will be taped to subjects skin). 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 after sham catheter placement.	Drug: 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; Other Names: Pain control post cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitate and report changes in pain scores reported by subject	Pain scores will be recorded at baseline and at two hour intervals. The patients are asked to report their pain on a scale of 0 to 10 with 0 being no pain and 10 is the most imaginable. The variables will be presented as mean and standard deviation.	First 2 days post surgical intervention
Quantitate the amount of opioid medication required to provide pain relief	To assess if either route (IV or ESP catheter) of lidocaine provided maximal pain relief when compared to its counterpart, the type and amount of medication provided the subject will be recorded. The amounts of opioid medications required to provide relief during the first 48 hours will be tabulated in morphine equivalents. A comparison will be made between the two route to see if one route is optimal over the other. The variables will be presented as mean and standard deviation.	First 2 days post surgical intervention

Collaborators and Investigators

• Sponsor: Archit Sharma
• Investigators: Principal Investigator: Archit Sharma, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Actual): April 7, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 202009510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No