Nerve BlockNCT04298580
Timing Effect of Ultrasound-Guided PVB After Robotic Cardiac Surgery
A study testing PVB block in people with Nerve Block and Cardiac Surgery, run by Cedars-Sinai Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nerve Block, Cardiac Surgery
- What is being tested?
- PVB block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 yrs
- ASA I-IV
- Either gender
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- PVB block
- Keywords
- Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVB blockProcedure or surgery
PVB block before surgery versus after surgery
| Study group | Role | What they receive |
|---|---|---|
| PVB before surgery | Active comparator | Not described Receives: Procedure: PVB block |
| PVB after surgery | Active comparator | Not described Receives: Procedure: PVB block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Durations of ICU and hospitalization
Duration (days) of ICU stay, and duration of hospital stay
Measured: 2-6 days
Secondary outcomes (1)
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)
Measured: 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 Sep 2020 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manxu Zhao, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298580
- Sponsor's protocol ID
- STUDY00000203
- Status last verified
- Jul 2020
- First submitted
- 25 Feb 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-Blinded Study to Evaluate the Timing Effect of Ultrasound-Guided Paravertebral Block in Patients Undergoing Robotic Mitral Valve Repair Procedure
- ClinicalTrials.gov ID
- NCT04298580
- Acronym / sponsor ID
- STUDY00000203
- Conditions
- Nerve Block, Cardiac Surgery
- Keywords
- Postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVB before surgery | Active comparator | Procedure: PVB block |
| PVB after surgery | Active comparator | Procedure: PVB block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 yrs
- ASA I-IV
- Either gender
Key exclusion criteria (7 listed)
- Refusal to participate in the study
- Age< 18 yrs
- Contraindications to regional blockage including but not limited to:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVB blockPVB block before surgery versus after surgery | Procedure or surgery | PVB after surgery, PVB before surgery |
Primary outcome
Durations of ICU and hospitalization
Time frame: 2-6 days
Duration (days) of ICU stay, and duration of hospital stay
1 secondary outcome
Pain intensity measure
Time frame: 2-3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing PVB block in people with Nerve Block and Cardiac Surgery, run by Cedars-Sinai Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manxu Zhao, MD (310-423-5841, manxu.zhao@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Durations of ICU and hospitalization (time frame: 2-6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.