Sponsor study identifier
interventional
24
1 country
1
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2014
Actual (reported)Study Completion
January 2014
Actual (reported)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 Tq time has elapsed, whichever occurs first. The subject's discomfort level (VAS) just prior to deflation will be recorded. Since Tq pressure alone can inhibit nerve function, we will monitor motor and sensory function distal to the Tq every 10 minutes during Tq inflation and for 30 minutes after Tq deflation. One to two weeks after this initial study, the same 20 subjects will receive SRA on the same arm and the same parameters will be measured. The 10 subjects who received 0.25% Bupivacaine the first time will receive Normal Saline, and the 10 subjects who received Normal Saline the first time will receive 0.25% Bupivacaine. In this way, each subject will act as his or her own control.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 25, 2013
Actual (reported)April 2013
Date type not reportedThis date has not been verified as actual or estimated.
April 11, 2013
Actual (reported)January 2014
Actual (reported)January 2014
Actual (reported)October 22, 2015
Actual (reported)Time in Minutes That Tq Remained Inflated
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.
Tq was inflated 15 minutes after injection of Bupivacaine or placebo and remained inflated until subject could no longer tolerate it. Maximum allowable inflation time per session was 60 minutes.
Pain Score at Time of Tq Deflation
Tq will be deflated upon subject's request. VAS is assessed at time of deflation for degree of discomfort prompting deflation request, up to 60 minutes post intervention.
A subcutaneous axillary ring of 10 to 15 mL of 0.25% Bupivacaine with epinephrine 1:200,000 will be injected in the arm 15 minutes prior to tourniquet inflation.
A subcutaneous axillary ring of 10 to 15 mL of normal saline will be injected in the arm 15 minutes prior to tourniquet inflation.
10-15 mL 0.25% Bupivicaine with epinephrine 1:200,000 subcutaneous axillary ring
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Bupivacaine with Epinephrine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordUniversity of North Carolina at Chapel Hill Medical Center
Chapel Hill, North Carolina, 27599, United States
Originally this was designed as a crossover study. However, there was a very strong crossover effect which invalidated the results from the second series of injections. Therefore, we have only analyzed the data from the first visit.
Randall F Coombs, M.D.
University of NC at Chapel Hill Dept. of Anesthesiology
24 participants (actual enrollment reported by the registry).
First Submitted
March 25, 2013
First Posted
April 11, 2013
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
January 2014
Actual (reported)Study Completion
January 2014
Actual (reported)Last Updated
October 22, 2015
Results First Posted
October 22, 2015
Record last verified: 2015-10
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Source: ClinicalTrials.gov.
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