Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01829399 · ClinicalTrials.gov registry record · Phase 4
Control of Tourniquet Pain With an Axillary Ring of Subcutaneous Local Anesthetic
A Phase 4 study of Application Site Discomfort and Medical Device Discomfort, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01829399 is a Phase 4 study of Application Site Discomfort and Medical Device Discomfort that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 24 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01829399, a Phase 4 study of Application Site Discomfort and Medical Device Discomfort, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Purpose: Even with excellent regional anesthesia of the upper extremity, tourniquet (Tq) pain from an upper arm Tq can limit the ability to use regional anesthesia as the primary anesthetic for surgical procedures on the upper extremity. The aim of this study is to determine whether a subcutaneous ring of local anesthetic on the inner aspect of the upper arm just distal to axillary crease will significantly diminish Tq pain. If it does, peripheral nerve blocks distal to the Tq (i.e., nerve blocks at the elbow) could be used as the primary anesthetic for surgery of the hand and forearm. These distal peripheral nerve blocks have fewer complications than brachial plexus blocks performed at higher levels, and, postoperatively, the patient has better control of his or her arm when distal nerve blocks are used. Procedures (methods): This is a prospective, cross-over study to examine the effectiveness of an upper arm Subcutaneous ring of local anesthetic alone in relieving Tq pain. This Subcutaneous ring of local anesthetic is often referred to as "Intercostobrachial nerve block" or "Subcutaneous ring anesthesia (SRA)." Twenty volunteers will be randomized into four groups of 5 participants each. During the initial experiment, the first group will be given SRA with 10-15 mL of 0.25% Bupivacaine with Epinephrine 1:200,000 on their dominant arm, the second group will be given SRA with 10-15 mL of 0.25% Bupivacaine with Epinephrine 1:200,000 on their non-dominant arm, the third group will be given "sham" SRA with saline on their dominant arm, and the fourth group will be given "sham" SRA with saline on their non-dominant arm. 15 minutes after SRA, a Tq will be applied to the arm with the subcutaneous injection and it will be inflated to 100 mm Hg above the subject's baseline systolic blood pressure. We will monitor heart rate, blood pressure (opposite arm) and pain (0 to 10 VAS) every 5 minutes. Each Tq will be released when the subject requests deflation or when 1 hour of T
Conditions Studied
Interventions
- DRUG Normal Saline
- DRUG Bupivacaine with Epinephrine
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill Medical Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01829399
The ClinicalTrials.gov registry entry for NCT01829399 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Application Site Discomfort appearing as the primary indexed condition, and to 2 interventions - of which Normal Saline is the first listed.
NCT01829399 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01829399 about?
NCT01829399 is a clinical study titled "Control of Tourniquet Pain With an Axillary Ring of Subcutaneous Local Anesthetic". Purpose: Even with excellent regional anesthesia of the upper extremity, tourniquet (Tq) pain from an upper arm Tq can limit the ability to use regional anesthesia as the primary anesthetic for surgical procedures on the upper extremity. The aim of this study is to determine whether a subcutaneous r...
What is the current status of trial NCT01829399?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2013-04. Estimated completion is 2014-01.
What conditions does trial NCT01829399 study?
This clinical trial studies the following conditions: Application Site Discomfort, Medical Device Discomfort.
What interventions are being tested in trial NCT01829399?
The interventions under investigation include: Normal Saline (DRUG), Bupivacaine with Epinephrine (DRUG).
Who is sponsoring clinical trial NCT01829399?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01829399 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Explore more on PlainTrial
Application Site Discomfort
All registered trials for this condition
Medical Device Discomfort
All registered trials for this condition
North Carolina
All trials with a study site in North Carolina
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.