Continuous Subpleural Infusion of Bupivacaine
Public ClinicalTrials.gov record NCT01566838. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Randomized Controlled Trial of Continuous Subpleural Infusion of Bupivacaine After Thoracoscopy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 between the study groups using student's t-tests and Wilcoxon rank-sum tests. Secondary outcomes, overall sum of pain scores through postoperative day 7, then at day 30 post-operatively, hospital length of stay, and overall hospital cost, will also be compared among study groups using student's t-tests and Wilcoxon rank-sum tests.
Study identification
- NCT ID
- NCT01566838
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 83 participants
Conditions and interventions
Conditions
Interventions
- Subpleural pain catheter with infusion of 0.125% bupivacaine Drug
- Standard acute pain management Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2012
- Primary completion
- Nov 30, 2015
- Completion
- Nov 30, 2015
- Last update posted
- Dec 19, 2017
2012 – 2015
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01566838, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 19, 2017 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01566838 live on ClinicalTrials.gov.