Timing Effect of Ultrasound-Guided PVB After Robotic Cardiac Surgery

NCT ID: NCT04298580

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-03-31

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.

Conditions

Nerve Block; Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

PVB before surgery

Group Type: ACTIVE_COMPARATOR

PVB block

Intervention Type: PROCEDURE

PVB block before surgery versus after surgery

PVB after surgery

Group Type: ACTIVE_COMPARATOR

PVB block

Intervention Type: PROCEDURE

PVB block before surgery versus after surgery

Interventions

PVB block

PVB block before surgery versus after surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Manxu Zhao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Manxu Zhao, MD

Role: CONTACT

manxu.zhao@cshs.org

310-423-5841

Other Identifiers

STUDY00000203

Identifier Type: -

Identifier Source: org_study_id