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NCT01566838 · ClinicalTrials.gov registry record · NA
Continuous Subpleural Infusion of Bupivacaine
A NA study, sponsored by Inova Health Care Services.
- Completed
- Registry status
- NA
- Development phase
- 83
- Enrollment target
NCT01566838 is a NA study that has completed, run by Inova Health Care Services. The registered enrollment target is 83 participants.
The verdict
NCT01566838, a NA study, has completed, sponsored by Inova Health Care Services.
- COMPLETED
- Registry status
- NA
- Development phase
- 83 participants
- Enrollment target
Study Summary
Rationale: For the past 3 years the investigators have routinely used an axial subpleural tunneling technique that del Study Design: All patients over the age of 18 having an isolated thoracoscopic procedure performed at Inova Fairfax Hospital for therapeutic or diagnostics purposes will be screened. Patients will be excluded if they have: previous ipsilateral thoracic surgery, need for operative pleurectomy or pleurodesis, chronic use of pain medication, sedatives or hypnotics, drug allergies, liver dysfunction, renal dysfunction, history of peptic ulcerative disease, sleep apnea in need of Bipap, severe chronic obstructive pulmonary disease (COPD), inability to consent, or are pregnant. All patients included will be screened, consented, and operated on by the one year anniversary of institutional review board (IRB) approval. Study Methodology: Eighty-six consented patients will be randomized into the study arm (use of a pain catheter with 0.125% bupivacaine) or the standard of care group (no pain catheter). The primary outcome is the use of narcotic pain medication post-operatively, compared between study groups. Secondary outcomes will include postoperative pain scores, hospital and length of stay. The On-Q pump delivers local anesthetic to the intercostal space, without leakage elsewhere, creating a functional multi level rib block. Despite positive subjective results, objective data is lacking. The investigators have also noted that some patients develop an annoying short term paresthesia that has been minimized by using lower anesthetic concentrations than described in other publications. Objectives: To evaluate visual analog pain scores post-operatively up to 30 days post-operative, and to determine any association between pain management and length of stay. Study Type: A prospective randomized 2-arm study will be performed. Statistical Methodology: Total amount of narcotic pain medication administered through postoperative day 7, will be compared betwee
Interventions
- DRUG Subpleural pain catheter with infusion of 0.125% bupivacaine
- DRUG Standard acute pain management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2012-10 |
| Est. Completion | 2015-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01566838
The ClinicalTrials.gov registry entry for NCT01566838 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inova Health Care Services, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Subpleural pain catheter with infusion of 0.125% bupivacaine is the first listed.
NCT01566838 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01566838 about?
NCT01566838 is a clinical study titled "Continuous Subpleural Infusion of Bupivacaine". Rationale: For the past 3 years the investigators have routinely used an axial subpleural tunneling technique that del Study Design: All patients over the age of 18 having an isolated thoracoscopic procedure performed at Inova Fairfax Hospital for therapeutic or diagnostics purposes will be screene...
What is the current status of trial NCT01566838?
This trial is currently completed. It is a NA study. The enrollment target is 83 participants. The study started on 2012-10. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01566838?
The interventions under investigation include: Subpleural pain catheter with infusion of 0.125% bupivacaine (DRUG), Standard acute pain management (DRUG).
Who is sponsoring clinical trial NCT01566838?
This trial is sponsored by Inova Health Care Services, which has 75 total clinical trials registered on ClinicalTrials.gov.
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