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

NCT04995497 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 202009510
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-Cumulative First 48 Hours

  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. Cumulative opioid usage amounts 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 median and interquartile range.

  48 hours post surgical intervention

• Compare Pain Score Reported by Subject 48 Hours Postoperatively

  Using a Numeric Rating Scale, 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 median and interquartile range.

  48 hours post surgical intervention

Secondary Outcomes (4)

• Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-0 to 24 Hours Post Surgical Intervention

  First 24 hours post surgical intervention

• Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-24 to 48 Hours Post Surgical Intervention

  From 24 to 48 hours post surgical intervention

• Pain Score at 24 Hours Postoperatively

  24 hours post surgical intervention

• Quantify the Number of Subjects Who Had Lidocaine Plasma Levels Greater Than 5 Micrograms/Milliliter.

  24 hours post intervention

Study Arms (2)

Erector Spinae Plane Block-Administration of Lidocaine

EXPERIMENTAL

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

Intravenous-Administration of Lidocaine

ACTIVE COMPARATOR

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.

Drug: Intravenous Administration of Lidocaine Post Cardiac Surgery

Interventions

Intravenous Administration of Lidocaine Post Cardiac Surgery 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

Also known as: Pain control post cardiac surgery

Intravenous-Administration of Lidocaine

Administration of Lidocaine Post Cardiac Surgery via ESP Catheter 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

Also known as: Pain control post cardiac surgery

Erector Spinae Plane Block-Administration of Lidocaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing elective cardiac surgery for coronary artery bypass graft (CABG) or valve surgery via sternotomy.
• English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Archit Sharma: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Limitations and Caveats

Ours is a single center trial. This likely should be investigated at multiple institutions with different surgical anesthesia groups for proper validation.

Results Point of Contact

• Title: Archit Sharma, M.D.
• Organization: University of Iowa Healthcare

archit-sharma@uiowa.edu

(319) 384-7911

Study Officials

• Archit Sharma, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 9, 2021
• Study Start: August 15, 2021
• Primary Completion: April 7, 2023
• Study Completion: April 30, 2023
• Last Updated: April 9, 2025
• Results First Posted: September 4, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)