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: Completed Phase 4 study of Application Site Discomfort and Medical Device Discomfort, sponsored by University of North Carolina, Chapel Hill.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
15 minutes after either Bupivacaine or placebo injection, Tq was inflated to 100 mm Hg over subjects systolic blood pressure. When the subject found the Tq too uncomfortable, the Tq was deflated and the time documented. Approximately one month later, each subject had the opposite injection of either placebo or Bupivacaine on the same arm, and the duration of Tq inflation was again measured. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed.
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 |
What the finished NCT01829399 record still lists
NCT01829399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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
How this trial's enrollment target compares
Where NCT01829399's enrollment target sits among peer trials
24 1699th of 2000 higher than 277 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02331979 · 24 participants · NA
Improving Bladder Function in SCI by Neuromodulation
- NCT03096197 · 24 participants · NA
Exoskeleton and Spinal Cord Stimulation for SCI
- NCT03223922 · 24 participants · NA
Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases
- NCT03326921 · 24 participants · Phase 1
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia