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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: Completed NA study, sponsored by Inova Health Care Services.

NCT01566838 is a NA study that has completed, run by Inova Health Care Services. The registered enrollment target is 83 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

The primary outcome will measure narcotics usage from post-operative day 1 through post-operative day 30.

Interventions

  • DRUG Subpleural pain catheter with infusion of 0.125% bupivacaine
  • DRUG Standard acute pain management

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2012-10
Est. Completion 2015-12
Phase NA
Inova Health Care Services

75 total trials

What the finished NCT01566838 record still lists

NCT01566838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

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 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01566838's enrollment target sits among peer trials

83 990th of 2000 higher than 1,011 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01566838, the US trial registry maintained by the National Library of Medicine. NCT01566838 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.