Clinical trial NCT04282239: Pectoral Nerves Block to Relieve Post-sternotomy Pain After Cardiac Surgery
Official title: Pectoral Nerves Block to Relieve Post-sternotomy Pain After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain, Postoperative
Cardiac Surgery
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine if the addition of PECS2 block provides superior post-operative analgesia for cardiac surgery patients after midline sternotomy compared to only standard-of-care post-operative pain medication.

Detailed description: The current study is a prospective, double-blind study investigating the use of pectoral nerves (PECS) block 2 to alleviate post-operative pain in cardiac surgery patients. The investigators anticipate enrolling a total of 220 participants in one of two groups, an interventional PECS block group and a control group not receiving the block. The intervention will occur in the operating room after the completion of the cardiac procedure and prior to the transfer of the participants to the cardiothoracic intensive care unit (CTICU). Both groups will receive the standard-of-care (SOC) pain regimen; the intervention with receive the PECS block in addition to SOC pain regimen. The procedure takes approximately five to ten minutes and will be conducted by the attending cardiac anesthesiologist. Pain will then be monitored hourly in the post-operative period in the CTICU. Additional measures will be investigated that are regularly logged in the electronic medical record.

Eligibility criteria: Inclusion Criteria:

1. Obtaining one or more of the following elective surgical procedures at NYU Winthrop Hospital with midline sternotomy:

   * Coronary artery bypass graft (any number of vessels)
   * Aortic Valve Replacement (AVR)
   * Aortic Valve Repair
   * Mitral Valve Replacement (MVR)
   * Mitral Valve Repair
   * Tricuspid Valve Replacement
   * Tricuspid Valve Repair
   * Pulmonic Valve replacement
   * Pulmonic Valve Repair
   * Congenital Heart Defect Repair
   * Ascending Thoracic Aortic Aneurism Repair
   * Patient Age \> 18 years.
2. Willingness and ability to participate in the study procedures
3. Sufficiently hemodynamically stable to give consent

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

* Hemodynamic instability
* Preexisting infection at site of block
* Allergy to block agents
* Severe psychiatric illness
* Intubated emergently prior to reception by the perioperative team
* Patient is preoperatively on extracorporeal membrane oxygenation (ECMO) treatment.
* Pregnant patient
* Recent surgery

Primary outcomes:
measure: Score on Critical-Care Pain Assessment Tool (CPOT)
timeFrame: 24 hours
measure: Score on Visual Analog Scale (VAS)
timeFrame: 24 hours
Secondary outcomes:
measure: Ventilatory duration post-operatively
timeFrame: 0-6 hours
measure: Duration of surgery
timeFrame: 4-6 hours
measure: Duration of operating room time
timeFrame: 5-7 hours
measure: Total intraoperative fentanyl dose
timeFrame: Intraoperative duration
measure: Duration of ICU stay
timeFrame: 24-48 hours
measure: Duration of hospital stay
timeFrame: 5-7 days post-operative
measure: Time to first opiate dose for breakthrough pain
timeFrame: 24-48 hours
measure: Time to first analgesic post-operatively
timeFrame: 24-48 hours
measure: Number of episodes of post-operative breakthrough pain
timeFrame: 24-48 hours
measure: Total post-operative opiate dose
timeFrame: 5-7 days post-operative
measure: Score on Critical-Care Pain Assessment Tool (CPOT) at 24-48h
timeFrame: 24-48 hours
measure: Score on Visual Analog Scale (VAS) at 24-48h
timeFrame: 24-48 hours
measure: Number of adverse events related to safety of the nerve block
timeFrame: 5-7 days post-operative
Other outcomes:
Locations:
city: Mineola
country: United States
facility: NYU Winthrop Hospital
state: New York
Study officials:
affiliation: NYU Langone Health
name: Sunil Abrol, MD
role: PRINCIPAL_INVESTIGATOR
References: