The Use of Serratus Block for Cardiac Surgery

The purpose of this randomized, un-blinded study is to determine if serratus blocks or Patient Controlled Analgesia (PCA)-alone (no block) offer patients adequate pain relief. This study will compare two standard of care pain management options and the patients narcotic requirements in the immediate postoperative period.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Procedure: Anesthetic regimen including SB; Procedure: Anesthetic regimen including SB or no block

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients over the age of 18 years of age undergoing robotic cardiac surgery.

Exclusion Criteria:

• Patients who are not candidates for serratus block

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Serratus blocks; The serratus plane is interstitial tissue, below the serratus muscle. The injection of bupivacaine numbs the anterior branch of the thoracodorsal nerve. This technique allows for the medication to diffuse along the area of the serratus plane to provide numbing of that area. Upon completion of the block, the patient will be evaluated for extubation and emerged from general anesthesia if appropriate.	Procedure: Anesthetic regimen including SB; Group receiving general anesthesia with the serratus block
Active Comparator: PCA-alone (no block); All subjects will receive fentanyl intravenous patient controlled anesthesia pumps as part of standard care. The amount of fentanyl self-administered by the patient or given by a clinician during 24 hours following surgery will be compared amongst the two groups.	Procedure: Anesthetic regimen including SB or no block; Group receiving general anesthesia alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of intravenous opiates used during the immediate postoperative period	The primary endpoint of the study will be comparison of the amount of intravenous opiates used during the immediate postoperative period between the 2 groups, the group receiving general anesthesia with the serratus block and the group receiving general anesthesia alone.	24 Hours

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Jennie Ngai, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Actual): November 13, 2017
• Study Completion (Actual): November 13, 2017

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 2, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Robotic Cardiac Surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 17-00070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No