CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Ropivacaine 0.75%, 20ml +5 moredrug
Likely dose
Ropivacaine 0.75%, 20mlfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02175069
NCT02175069Phase 4Completed

Magnetic Resonance Imaging of Local Anesthetic Distribution: A Comparison of 5 and 15 Milliliters of Ropivacaine 0,75% for Ultrasound Guided Interscalene Plexus Blockade

Paracelsus Medical University·interventional·Posted Jun 26, 2014·Updated Jul 10, 2014

In Brief

A Phase 4 clinical trial evaluating Interscalene Nerve Block, Ropivacaine 0.75%, 20ml, and 4 other interventions for Disorder of Shoulder. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Interscalene plexus block is a widely used technique to provide anesthesia and analgesia for surgery at the upper extremity (shoulder and upper arm); it is standard-of-care in many institutions worldwide. Local anesthetic is being injected around the nerves supplying the arm (Plexus brachialis) at a specific location in the arm (between the scalenus muscles, thus called "interscalene plexus block"). The optimal volume of injection with regard to efficacy, safety and avoidance of untoward effects has been subject to intense debate for a long time. In spite of evidence that small volumes (between 5 and 7 mls) are effective for adequate postoperative analgesia, larger volumes up to 40 mls are still frequently used in many practices. However, with the use of such large doses, adverse events are known to occur with increased frequency, including paralysis of the diaphragm or spread of local anesthetic to the spinal cord. This study is intended to help evaluate the effects of small or larger injection of local anesthetic around the brachial plexus, and to correlate the distribution with clinical efficacy, block duration, and possible side effects. It is a randomized, controlled, observer-blinded trial; patients undergoing shoulder or upper arm surgery will be randomly allocated to receive either 5mls or 20mls of local anesthetic for their interscalene plexus block. Magnetic resonance imaging will be performed immediately afterwards, followed by a series of neurological exams during the hospital stay. Test of lung function (spirometry) and ultrasound of the diaphragm will be used to evaluate effects of the block on respiratory mechanics.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 26, 2014
Enrollment StartDec 1, 2013
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.0 years ago

Interventions

Interscalene Nerve Blockprocedure

ultrasound guided interscalene plexus block (UISB) immediately before magnetic resonance imaging of the neck.

Ropivacaine 0.75%, 20mldrug

20 ml of ropivacaine 0.75%

Gadopentetate-Dimeglumine 0.0125 mmoldrug

0.0125 mmol of gadopentetate-dimeglumine

Gadopentetate-Dimeglumine 0.05 mmoldrug

0.05 mmol of gadopentetate-dimeglumine

Ropivacaine 0.75%, 5mldrug

5 ml of ropivacaine 0.75%

Shoulder Surgeryprocedure

As per individual requirement (patient-dependent)