The Use of Serratus Block for Cardiac Surgery

NCT03237546 | Completed

• 1 other identifier: 17-00070
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Surgery

Keywords

Robotic Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Serratus blocks

ACTIVE COMPARATOR

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

PCA-alone (no block)

ACTIVE COMPARATOR

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

Interventions

Anesthetic regimen including SB PROCEDURE

Group receiving general anesthesia with the serratus block

Serratus blocks

Anesthetic regimen including SB or no block PROCEDURE

Group receiving general anesthesia alone

PCA-alone (no block)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who are not candidates for serratus block

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Study Officials

• Jennie Ngai, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 2, 2017
• Study Start: July 17, 2017
• Primary Completion: November 13, 2017
• Study Completion: November 13, 2017
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

US (1)