Timing Effect of Ultrasound-Guided PVB After Robotic Cardiac Surgery

Not Applicable

• Conditions: Cardiac Surgery; Nerve Block
• Interventions: Procedure: PVB block

• Registration Number: NCT04298580
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-06
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-24
• Study Start: 2020-09-01
• Primary Completion: 2021-02-28
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVB after surgery	PVB block	-
PVB before surgery	PVB block	-

Primary Outcome Measures

Name	Time	Method
Durations of ICU and hospitalization	2-6 days	Duration (days) of ICU stay, and duration of hospital stay

Secondary Outcome Measures

Name	Time	Method
Pain intensity measure	2-3 days	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)