Timing Effect of Ultrasound-Guided PVB After Robotic Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04298580
• Other study ID #: STUDY00000203
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2020
• Source: Cedars-Sinai Medical Center
• Contact: Manxu Zhao, MD
• Phone: 310-423-5841
• Email: manxu.zhao[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Nerve Block

Intervention

Procedure:
• PVB block
PVB block before surgery versus after surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Durations of ICU and hospitalization	Duration (days) of ICU stay, and duration of hospital stay	2-6 days
Secondary	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