Pectus ExcavatumNCT02009267
Nuss Procedure: Clinical Options in Pediatric Pain Management?
An observational study of Pectus Excavatum, run by Ralph Beltran at 1 site in United States.
Trial summary
A retrospective chart review study analyzing the benefits of patient controlled analgesia, thoracic epidural analgesia, and paravertebral nerve block catheters in patients having surgical repair of pectus excavatum using the Nuss procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- Continuous thoracic epidural infusions and Continuous paravertebral blockade
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing the Nuss procedure to correct pectus excavatum at Nationwide Children's Hospital.
Who may be able to join
- Patients undergoing the NUSS procedure since the beginning of 2011 to Sept. 30th, 2013.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
A retrospective chart review study analyzing the benefits of patient controlled analgesia, thoracic epidural analgesia, and paravertebral nerve block catheters in patients having surgical repair of pectus excavatum using the Nuss procedure.
- Conditions
- Pectus Excavatum
- Being tested
- Patient controlled analgesia, Continuous thoracic epidural infusions, Continuous paravertebral blockade
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient controlled analgesiaDevice
A programable electronically controlled infusion pump that delivers an amount of intravenous analgesic when the patient presses a button.
Continuous thoracic epidural infusionsProcedure or surgery
Continuous thoracic epidural infusions (TE) involves continuous infusion of drugs through a catheter placed into the epidural space, resulting in a loss of sensation-including the sensation of pain-by blocking the transmission of signals through nerve fibers in or near the spinal cord.
Continuous paravertebral blockadeProcedure or surgery
Continuous paravertebral blockade (PVB) is the technique of injecting local anesthetic adjacent to the thoracic vertebra that anesthetizes the spinal nerve roots after they exit the spinal canal.
| Study group | Role | What they receive |
|---|---|---|
| Patient controlled analgesia | Use of patient controlled analgesia (PCA) for the management of postoperative pain after the Nuss procedure. Receives: Device: Patient controlled analgesia | |
| Continuous thoracic epidural infusion | Continuous thoracic epidural infusions (TE) for the management of postoperative pain after the Nuss procedure. Receives: Procedure: Continuous thoracic epidural infusions | |
| Continuous paravertebral blockade | Continuous paravertebral blockade (PVB) for the management of postoperative pain after the Nuss procedure. Receives: Procedure: Continuous paravertebral blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine dose
Total morphine dose will be evaluated in mg/kg/24 hour period, beginning with post-op day 0 until discharge from the hospital.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes (3)
Pain score
Pain scores obtained from the visual analog scale.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Length of hospitalization
Determine if there is a difference in length of hospitalization, and time to discharge.
Measured: Within the first week after surgery.
Nausea and vomiting
Determine the incidence of nausea and vomiting measured by the postoperative ondansetron dosing, beginning with arrival to floor and up to the first 48 hrs of hospitalization.
Measured: 0-48 hrs. post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ralph Beltran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ralph Beltran, Nationwide Children's Hospital
- Investigators
- Beltran Ralph, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009267
- Sponsor's protocol ID
- IRB13-00702
- Status last verified
- Feb 2017
- First submitted
- 19 Nov 2013
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nuss Procedure: Clinical Options in Pediatric Pain Management?
- ClinicalTrials.gov ID
- NCT02009267
- Acronym / sponsor ID
- IRB13-00702
- Conditions
- Pectus Excavatum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ralph BeltranUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Dec 2013 (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.
A retrospective chart review study analyzing the benefits of patient controlled analgesia, thoracic epidural analgesia, and paravertebral nerve block catheters in patients having surgical repair of pectus excavatum using the Nuss procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient controlled analgesia | – | Device: Patient controlled analgesiaUse of patient controlled analgesia (PCA) for the management of postoperative pain after the Nuss procedure. |
| Continuous thoracic epidural infusion | – | Procedure: Continuous thoracic epidural infusionsContinuous thoracic epidural infusions (TE) for the management of postoperative pain after the Nuss procedure. |
| Continuous paravertebral blockade | – | Procedure: Continuous paravertebral blockadeContinuous paravertebral blockade (PVB) for the management of postoperative pain after the Nuss procedure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing the Nuss procedure to correct pectus excavatum at Nationwide Children's Hospital.
Key inclusion criteria (1 listed)
- Patients undergoing the NUSS procedure since the beginning of 2011 to Sept. 30th, 2013.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Patient controlled analgesiaA programable electronically controlled infusion pump that delivers an amount of intravenous analgesic when the patient presses a button. | Device | Patient controlled analgesia |
| Continuous thoracic epidural infusionsContinuous thoracic epidural infusions (TE) involves continuous infusion of drugs through a catheter placed into the epidural space, resulting in a loss of sensation-including the sensation of pain-by blocking the transmission of signals through nerve fibers in or near the spinal cord. | Procedure or surgery | Continuous thoracic epidural infusion |
| Continuous paravertebral blockadeContinuous paravertebral blockade (PVB) is the technique of injecting local anesthetic adjacent to the thoracic vertebra that anesthetizes the spinal nerve roots after they exit the spinal canal. | Procedure or surgery | Continuous paravertebral blockade |
Primary outcome
Total morphine dose
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Total morphine dose will be evaluated in mg/kg/24 hour period, beginning with post-op day 0 until discharge from the hospital.
3 secondary outcomes
Pain score
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Length of hospitalization
Time frame: Within the first week after surgery.
Nausea and vomiting
Time frame: 0-48 hrs. post-op
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 2 Feb 2017.
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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.
Beltran Ralph, MD principal investigator
Nationwide Children's Hospital
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 Pectus Excavatum, run by Ralph Beltran 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 1 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 2 Feb 2017. 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?
Total morphine dose (time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 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 2 Feb 2017; AzTrials last refreshed its copy on 7 Nov 2026.