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

Primary Purpose

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

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intravenous Administration of Lidocaine Post Cardiac Surgery
Administration of Lidocaine Post Cardiac Surgery via ESP Catheter
Sponsored by
Archit Sharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erector Spinae Plane Block

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Erector Spinae Plane Block-Administration of Lidocaine

Intravenous-Administration of Lidocaine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2021
Last Updated
October 9, 2023
Sponsor
Archit Sharma
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1. Study Identification

Unique Protocol Identification Number
NCT04995497
Brief Title
Intravenous(IV) vs. Erector Spinae Plane Blocks in Cardiac Surgery
Official Title
IV vs. Erector Spinae Plane Blocks-Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Archit Sharma

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erector Spinae Plane Block, Pain Control, Post-Operative Pain, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector Spinae Plane Block-Administration of Lidocaine
Arm Type
Experimental
Arm Description
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.
Arm Title
Intravenous-Administration of Lidocaine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravenous Administration of Lidocaine Post Cardiac Surgery
Other Intervention Name(s)
Pain control post cardiac surgery
Intervention Description
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
Intervention Name(s)
Administration of Lidocaine Post Cardiac Surgery via ESP Catheter
Other Intervention Name(s)
Pain control post cardiac surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
Quantitate and report changes in pain scores reported by subject
Description
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.
Time Frame
First 2 days post surgical intervention
Title
Quantitate the amount of opioid medication required to provide pain relief
Description
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.
Time Frame
First 2 days post surgical intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Archit Sharma, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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