NCT04298580

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

February 25, 2020

Last Update Submit

July 23, 2020

Conditions

Nerve BlockCardiac Surgery

Keywords

Postoperative pain

Outcome Measures

Primary Outcomes (1)

  • Durations of ICU and hospitalization

    Duration (days) of ICU stay, and duration of hospital stay

    2-6 days

Secondary Outcomes (1)

  • Pain intensity measure

    2-3 days

Study Arms (2)

PVB before surgery

ACTIVE COMPARATOR
Procedure: PVB block

PVB after surgery

ACTIVE COMPARATOR
Procedure: PVB block

Interventions

PVB blockPROCEDURE

PVB block before surgery versus after surgery

PVB after surgeryPVB before surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 yrs
  • ASA I-IV
  • Either gender

You may not qualify if:

  • Refusal to participate in the study
  • Age\< 18 yrs
  • Contraindications to regional blockage including but not limited to:
  • Patient refusal to regional blockade
  • Infection at the site of needle insertion
  • Systemic infection
  • Bleeding diathesis or coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Manxu Zhao, MD

CONTACT

310-423-5841manxu.zhao@cshs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor will be blinded to study group
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2020

First Posted

March 6, 2020

Study Start

September 1, 2020

Primary Completion

February 28, 2021

Study Completion

March 31, 2021

Last Updated

July 24, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share