Pharmacokinetic of Thoracic Paravertebral Ropivacaine
The Pharmacokinetic of Ropivacaine in Patients Undergoing Ultrasound-guided Continuous Thoracic Paravertebral Block
1 other identifier
interventional
20
1 country
2
Brief Summary
The study aims to investigate the pharmacokinetic of ropivacaine in patients undergoing ultrasound guided thoracic paravertebral block (TPVB) both after a single-bolus injection via the thoracic paravertebral catheter given before the start of surgery and after continuous thoracic paravertebral infusion that will start after the end of the procedure in order to achieve postoperative analgesia after open thoracotomy during the first 3 postoperative days
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2019
Typical duration for not_applicable
2 active sites
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
October 23, 2018
CompletedFirst Posted
Study publicly available on registry
October 26, 2018
CompletedStudy Start
First participant enrolled
October 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2021
CompletedFebruary 16, 2022
February 1, 2022
2 years
October 23, 2018
February 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ropivacaine plasma levels
Ropivacaine plasma levels in both arterial and venous blood samples collected at regular intervals
up to 72 postoperative hours after the initiation of continuous thoracic paravertebral infusion of ropivacaine
Secondary Outcomes (1)
Clinical signs of local anesthetic toxicity
Up to 72 hours after the initiation of continuous thoracic paravertebral infusion of ropivacaine
Other Outcomes (1)
VAS scores
up to 72 postoperative hours after the initiation of continuous thoracic paravertebral infusion of ropivacaine
Study Arms (1)
Ropivacaine
OTHER* 25 ml single dose of 0.5% ropivacaine * continuous infusion of ropivacaine 0.2% with a constant infusion rate of 14 ml/h
Interventions
ropivacaine administerd via thoracic paraveretebral catheter
Eligibility Criteria
You may qualify if:
- Age \>18 years
- ASA I-III
- Open thoracotomy
You may not qualify if:
- Patient refusal
- Age \<18 years
- Morbid obesity
- Scoliosis
- Previous thoracotomy
- Empyema
- Drug allergy
- Severe systemic disease
- ASA \> III
- Hypoalbuminemia
- Urgent surgery
- Reoperation during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Attikon Hospitallead
Study Sites (2)
2nd Department of Anesthesiology, Attikon University Hospital
Athens, Attica, 12462, Greece
Paraskevi K Matsota
Athens, Other, 13231, Greece
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paraskevi K Matsota, Prof
2nd Department of Anaesthesiology, "Attikon" University Hospital, Athens
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc Prof of Anaesthesiology
Study Record Dates
First Submitted
October 23, 2018
First Posted
October 26, 2018
Study Start
October 8, 2019
Primary Completion
October 25, 2021
Study Completion
November 25, 2021
Last Updated
February 16, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share