Phase 2 N=70 Randomized Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT04995497 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-Cumulative First 48 Hours — 80.2; 54.9 Morphine Milligram Equivalents

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Intravenous Administration of Lidocaine Post Cardiac Surgery (Drug); Administration of Lidocaine Post Cardiac Surgery via ESP Catheter (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Archit Sharma
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-Cumulative First 48 Hours	80.2; 54.9	—
PRIMARY Compare Pain Score Reported by Subject 48 Hours Postoperatively	3; 2	—
SECONDARY Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-0 to 24 Hours Post Surgical Intervention	49.78; 39.00	—
SECONDARY Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-24 to 48 Hours Post Surgical Intervention	24.5; 22.5	—
SECONDARY Pain Score at 24 Hours Postoperatively	3.5; 5.0	—
SECONDARY Quantify the Number of Subjects Who Had Lidocaine Plasma Levels Greater Than 5 Micrograms/Milliliter.	2; 4	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04995497). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.