Timing Effect of Ultrasound-Guided PVB After Robotic Cardiac Surgery

Randomized, Single-Blinded Study to Evaluate the Timing Effect of Ultrasound-Guided Paravertebral Block in Patients Undergoing Robotic Mitral Valve Repair Procedure

This study is to evaluate whether the administration of ultrasound-guided paravertebral block (PVB) after surgery would produce better postoperative pain control and fast postoperative recovery after Robotic cardiac surgery. Half of participants will receive PVB before surgery, while the other half will receive PVB at the end of surgery.

Study Overview

• Status: Unknown
• Conditions: Cardiac Surgery; Nerve Block
• Intervention / Treatment: Procedure: PVB block

Detailed Description

Ultrasound-guided PVB (either before surgery, or after surgery) is the standard postoperative pain management for Robotic cardiac surgery. This technique is to inject local anesthetic (numb medication) around nerve to decrease pain. But the optimal time of PVB is unknown.

The administration of PVB before surgery can help pain control during the surgery and after surgery. But the duration of PVB could be reduced because surgery itself can last 5-6 hrs.

The PVB after surgery will not provide pain control during surgery, but may provide longer pain control after surgery, and may help participants faster recovery after surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 18 yrs
2. ASA I-IV
3. Either gender

Exclusion Criteria:

1. Refusal to participate in the study
2. Age< 18 yrs

3. Contraindications to regional blockage including but not limited to:

   1. Patient refusal to regional blockade
   2. Infection at the site of needle insertion
   3. Systemic infection
   4. Bleeding diathesis or coagulopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PVB before surgery	Procedure: PVB block; PVB block before surgery versus after surgery
Active Comparator: PVB after surgery	Procedure: PVB block; PVB block before surgery versus after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Durations of ICU and hospitalization	Duration (days) of ICU stay, and duration of hospital stay	2-6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity measure	self reported pain intensity at every 4 hour while in the ICU. It is a scored 0-10 (0 = no pain, 10 + pain as bad as can be)	2-3 days

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): February 28, 2021
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Postoperative pain
• Other Study ID Numbers: STUDY00000203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No