Clinical trial NCT04995497: Intravenous(IV) vs. Erector Spinae Plane Blocks in Cardiac Surgery
Official title: IV vs. Erector Spinae Plane Blocks-Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erector Spinae Plane Block
Pain Control
Post-Operative Pain, Chronic
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-Cumulative First 48 Hours
timeFrame: 48 hours post surgical intervention
measure: Compare Pain Score Reported by Subject 48 Hours Postoperatively
timeFrame: 48 hours post surgical intervention
Secondary outcomes:
measure: Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-0 to 24 Hours Post Surgical Intervention
timeFrame: First 24 hours post surgical intervention
measure: Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-24 to 48 Hours Post Surgical Intervention
timeFrame: From 24 to 48 hours post surgical intervention
measure: Pain Score at 24 Hours Postoperatively
timeFrame: 24 hours post surgical intervention
measure: Quantify the Number of Subjects Who Had Lidocaine Plasma Levels Greater Than 5 Micrograms/Milliliter.
timeFrame: 24 hours post intervention
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Archit Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References: