Serum Ropivacaine Concentrations in Pediatric Patients Receiving Continuous Wound Catheter Analgesia
1 other identifier
observational
4
1 country
1
Brief Summary
The primary investigators in this study plan to investigate serum concentrations of ropivacaine in pediatric patients who already receive as standard of care a continuous wound catheter after an iliac crest alveolar bone graft harvest for completion of a previous cleft palate repair. The goals of this study are 1) to determine serum concentrations (free, unbound) of ropivacaine 2) To evaluate pain scores during the perioperative period to determine efficacy of wound catheters for postoperative analgesia for iliac crest bone graft harvest.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2015
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 14, 2015
CompletedFirst Posted
Study publicly available on registry
August 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedAugust 5, 2019
August 1, 2019
3 years
August 14, 2015
August 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Unbound serum ropivicaine levels at postoperative day 0, 1, and 3
Three blood draws
three days
Secondary Outcomes (1)
Pain scores
Three days
Study Arms (1)
Iliac crest wound catheter group
These patients will receive an iliac crest wound catheter after an iliac crest bone harvest to repair a palatal defect. This catheter is part of standard of care. This study will collect blood to measure unbound ropivicaine levels.
Interventions
Eligibility Criteria
Pediatric patients that require an iliac crest bone harvest that requires an iliac crest wound catheter
You may not qualify if:
- Patient or parent/guardian refusal
- Ropivacaine allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Franklyn Cladis, MD
University of Pittsburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 14, 2015
First Posted
August 18, 2015
Study Start
August 1, 2015
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
August 5, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
If the participants would like to see their individual data, they may. If the data demonstrates that their plasma local anesthetic levels were high we will notify the participants and their guardians.