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NCT Number: NCT04995497

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

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Key information

Conditions

Erector Spinae Plane Block Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Control Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Post-Operative Pain, Chronic Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Pain control post cardiac surgery

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

Other names: Pain control post cardiac surgery

Primary outcomes

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

    Time frame: 48 hours post surgical intervention

    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.

  2. Compare Pain Score Reported by Subject 48 Hours Postoperatively

    Time frame: 48 hours post surgical intervention

    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.

Secondary outcomes

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

    Time frame: First 24 hours post surgical intervention

    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 opioid amounts required to provide relief during the first 24 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.

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

    Time frame: From 24 to 48 hours post surgical intervention

    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 opioid amounts required to provide relief 24 and 48 hours post surgical intervention 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.

  3. Pain Score at 24 Hours Postoperatively

    Time frame: 24 hours post surgical intervention

    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.

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

    Time frame: 24 hours post intervention

    All subjects will receive lidocaine via intravenous administration or through erector spinae plane block bilateral catheters. Arterial plasma levels monitoring the concentration of lidocaine will be checked at regular intervals. The number of subjects who reach levels above 5 micrograms/milliliter at the 24-hour timepoint will be reported.

Sponsors and collaborators

Lead sponsor

Archit Sharma

Other

Registry information

Official study title

IV vs. Erector Spinae Plane Blocks-Cardiac Surgery

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2021
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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