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

Erector Spinae Plane Block Clinical Trial

Official title:

IV vs. Erector Spinae Plane Blocks-Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04995497
• Other study ID #: 202009510
• Status: Completed
• Phase: Phase 2
• Start date: August 15, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: February 2024
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 30, 2023
• Est. primary completion date: April 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Erector Spinae Plane Block
• Pain Control
• Pain, Postoperative

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Archit Sharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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