Alveolar Bone GraftingNCT02526563
Serum Ropivacaine Concentrations in Pediatric Patients Receiving Continuous Wound Catheter Analgesia
An observational study of Alveolar Bone Grafting and Alveolar Cleft Grafting, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Alveolar Bone Grafting, Alveolar Cleft Grafting
- What is being tested?
- ropivicaine
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Aug 2018
- Phase
- Observational
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients that require an iliac crest bone harvest that requires an iliac crest wound catheter
Who may be able to join
- Inclusion criteria is any patient age ranging from 5 to 18 years of age that is scheduled for an iliac crest bone harvest that requires an iliac crest wound catheter
Who cannot join
- Patient or parent/guardian refusal
- Ropivacaine allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed description
There have been numerous investigations of serum concentration of ropivicaine using wound catheters in adults. These studies have revealed that wound catheters provide effective analgesia without toxic levels of serum ropivicaine. Our current proposal is different for two reasons. One, the investigators will be investigating the serum levels of ropivacaine in pediatric patients. There are currently no studies investigating the efficacy of this technique in the pediatric population. Two, the wound catheter currently being placed by Dr Losee (and plastic surgeons in other pediatric centers) as part of standard of care is different from other wound catheters. Most wound catheters described in the literature are placed in the surgical wound between muscle and facial planes. The catheter placed by Dr Losee for his routine postoperative pain control is placed adjacent to the periosteum and adjacent to the bone harvest site. Dr Losee has been performing this technique as part of standard patient care and it appears to provide excellent analgesia without side effects from the ropivacaine. However, it is unknown what effect this location has on serum plasma levels of ropivacaine. Measuring unbound ropivacaine will help define whether or not these wound catheters maintain the serum ropivacaine levels below, near, or above toxic levels. Pediatric studies have investigated the serum ropivacaine levels during epidural infusions and peripheral nerve blocks. This local anesthetic is safe as long as the administration is limited to weight based limits. For continuous infusions, ropivacaine should not be administered at a greater rate than 0.4 -0.5 mg/kg/hr. The wound catheters for The Childrens Hospital of Pittsburgh Plastic Surgery service are administered at 0.25 mg/kg/hr. Ropivacaine is the local anesthetic of choice for many pediatric hospitals and for the Acute Interventional Pediatric Pain Service at the Children's Hospital of Pittsburgh because it appears to have a slight safety advantage over bupivacaine. Ropivacaine does not bind sodium channels as avidly as bupivacaine and therefore may not be as cadiac toxic. However, the location of the catheter can alter absorption and may alter plasma levels. Currently there is no data for pediatric iliac crest wound catheters. Since this technique is already a standard of care here at this center, we plan to measure serum ropivacaine levels to define these values.
It is important to understand the dosages currently being used in this pediatric population and the effects on serum local anesthetic levels. When local anesthetic is infused through an epidural, peripheral nerve block, or wound catheter, there is an elevation in local anesthetic plasma levels in the patient. The plasma levels depend on the dose, concentration and location of the catheter. Current literature has defined the plasma levels obtained during continuous infusions of local anesthetic through wound catheters in adults. Safe infusion rates have been defined for adult catheters. This data does not exist for wound catheters in pediatric patients and this study will begin to define these limits. In particular, the catheter currently being placed as standard of care at The Children's Hospital of Pittsburgh is periostial and it is unknown what effect this location has on serum ropivacaine levels
- Conditions
- Alveolar Bone Grafting, Alveolar Cleft Grafting
- Being tested
- ropivicaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivicaineProcedure or surgery
Blood draws to measure serum ropivicaine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: ropivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unbound serum ropivicaine levels at postoperative day 0, 1, and 3
Three blood draws
Measured: three days
Secondary outcomes (1)
Pain scores
Measure of pain scores for the first three postoperative days
Measured: Three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone GraftingStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franklyn Cladis, University of Pittsburgh
- Investigators
- Franklyn Cladis, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526563
- Sponsor's protocol ID
- PRO14110169
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2015
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Ropivacaine Concentrations in Pediatric Patients Receiving Continuous Wound Catheter Analgesia
- ClinicalTrials.gov ID
- NCT02526563
- Acronym / sponsor ID
- PRO14110169
- Conditions
- Alveolar Bone Grafting, Alveolar Cleft Grafting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 18 Aug 2015 (estimated)
- 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.
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.
Detailed description
There have been numerous investigations of serum concentration of ropivicaine using wound catheters in adults. These studies have revealed that wound catheters provide effective analgesia without toxic levels of serum ropivicaine. Our current proposal is different for two reasons. One, the investigators will be investigating the serum levels of ropivacaine in pediatric patients. There are currently no studies investigating the efficacy of this technique in the pediatric population. Two, the wound catheter currently being placed by Dr Losee (and plastic surgeons in other pediatric centers) as part of standard of care is different from other wound catheters. Most wound catheters described in the literature are placed in the surgical wound between muscle and facial planes. The catheter placed by Dr Losee for his routine postoperative pain control is placed adjacent to the periosteum and adjacent to the bone harvest site. Dr Losee has been performing this technique as part of standard patient care and it appears to provide excellent analgesia without side effects from the ropivacaine. However, it is unknown what effect this location has on serum plasma levels of ropivacaine. Measuring unbound ropivacaine will help define whether or not these wound catheters maintain the serum ropivacaine levels below, near, or above toxic levels. Pediatric studies have investigated the serum ropivacaine levels during epidural infusions and peripheral nerve blocks. This local anesthetic is safe as long as the administration is limited to weight based limits. For continuous infusions, ropivacaine should not be administered at a greater rate than 0.4 -0.5 mg/kg/hr. The wound catheters for The Childrens Hospital of Pittsburgh Plastic Surgery service are administered at 0.25 mg/kg/hr. Ropivacaine is the local anesthetic of choice for many pediatric hospitals and for the Acute Interventional Pediatric Pain Service at the Children's Hospital of Pittsburgh because it appears to have a slight safety advantage over bupivacaine. Ropivacaine does not bind sodium channels as avidly as bupivacaine and therefore may not be as cadiac toxic. However, the location of the catheter can alter absorption and may alter plasma levels. Currently there is no data for pediatric iliac crest wound catheters. Since this technique is already a standard of care here at this center, we plan to measure serum ropivacaine levels to define these values.
It is important to understand the dosages currently being used in this pediatric population and the effects on serum local anesthetic levels. When local anesthetic is infused through an epidural, peripheral nerve block, or wound catheter, there is an elevation in local anesthetic plasma levels in the patient. The plasma levels depend on the dose, concentration and location of the catheter. Current literature has defined the plasma levels obtained during continuous infusions of local anesthetic through wound catheters in adults. Safe infusion rates have been defined for adult catheters. This data does not exist for wound catheters in pediatric patients and this study will begin to define these limits. In particular, the catheter currently being placed as standard of care at The Children's Hospital of Pittsburgh is periostial and it is unknown what effect this location has on serum ropivacaine levels
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iliac crest wound catheter group | – | Procedure: ropivicaineThese 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients that require an iliac crest bone harvest that requires an iliac crest wound catheter
Key inclusion criteria (1 listed)
- Inclusion criteria is any patient age ranging from 5 to 18 years of age that is scheduled for an iliac crest bone harvest that requires an iliac crest wound catheter
Key exclusion criteria (2 listed)
- Patient or parent/guardian refusal
- Ropivacaine allergy
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 |
|---|---|---|
| ropivicaineBlood draws to measure serum ropivicaine | Procedure or surgery | Iliac crest wound catheter group |
Primary outcome
Unbound serum ropivicaine levels at postoperative day 0, 1, and 3
Time frame: three days
Three blood draws
1 secondary outcome
Pain scores
Time frame: Three days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Individual participant dataSharing planned: Yes. 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.
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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.
Franklyn Cladis, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alveolar Bone Grafting and Alveolar Cleft Grafting, run by University of Pittsburgh at 1 site in United States.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unbound serum ropivicaine levels at postoperative day 0, 1, and 3 (time frame: three 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 5 Aug 2019.