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NCT01450007 · ClinicalTrials.gov registry record · Phase 4
Ropivacaine Block Alone or With Perineural or Systemic Dexamethasone for Pain in Shoulder Surgery
A Phase 4 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 130
- Enrollment target
NCT01450007: Completed Phase 4 study, sponsored by Mayo Clinic.
NCT01450007 is a Phase 4 study that has completed, run by Mayo Clinic. The registered enrollment target is 130 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01450007, a Phase 4 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 130 participants
- Enrollment target
Study Summary
Pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia, improve visual analog pain scores, decrease post-operative opioid use, and decrease post-operative nausea. No study has been published to determine if this effect is a result of systemic absorption of dexamethasone or is a local effect of the drug on neuronal activity at the injection site. This study is a prospective, randomized, double-blind, controlled study to compare pain block with (1) ropivacaine and saline plus intravenous saline vs (2) ropivacaine and dexamethasone plus intravenous saline vs (3) ropivacaine and saline plus intravenous dexamethasone. Patients will be recruited sequentially and assigned to the three groups at random in equal ratios. The hypothesis is that dexamethasone injected perineurally in combination with ropivacaine for interscalene brachial plexus block will yield longer duration of sensory blockade as compared to ropivacaine alone without intravenous or perineural dexamethasone and as compared to ropivacaine and intravenous dexamethasone. This result will suggest that the effect of dexamethasone is a result of direct neuronal activity at the injection site versus systemic absorption.
Interventions
- DRUG Dexamethasone
- DRUG Normal saline
- DRUG Ropivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01450007
The ClinicalTrials.gov registry entry for NCT01450007 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT01450007 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01450007 about?
NCT01450007 is a clinical study titled "Ropivacaine Block Alone or With Perineural or Systemic Dexamethasone for Pain in Shoulder Surgery". Pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia, improve visual analog pain scores, decrease post-operative opioid use, and decrease post-operative nausea. No study h...
What is the current status of trial NCT01450007?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 130 participants. The study started on 2012-05. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01450007?
The interventions under investigation include: Dexamethasone (DRUG), Normal saline (DRUG), Ropivacaine (DRUG).
Who is sponsoring clinical trial NCT01450007?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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