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

Phase 2

Completed

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

Interventions: Drug: Administration of Lidocaine Post Cardiac Surgery via ESP Catheter
Drug: Intravenous Administration of Lidocaine Post Cardiac Surgery

Registration Number: NCT04995497

Lead Sponsor: Archit Sharma

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 70

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane Block-Administration of Lidocaine	Administration of Lidocaine Post Cardiac Surgery via ESP Catheter	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.
Intravenous-Administration of Lidocaine	Intravenous Administration of Lidocaine Post Cardiac Surgery	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.

Primary Outcome Measures

Name	Time	Method
Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-Cumulative First 48 Hours	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.
Compare Pain Score Reported by Subject 48 Hours Postoperatively	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 Outcome Measures

Name	Time	Method
Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-0 to 24 Hours Post Surgical Intervention	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.
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	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.
Pain Score at 24 Hours Postoperatively	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.
Quantify the Number of Subjects Who Had Lidocaine Plasma Levels Greater Than 5 Micrograms/Milliliter.	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.