Control of Tourniquet Pain With an Axillary Ring of Subcutaneous Local Anesthetic
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|ClinicalTrials.gov Identifier: NCT01829399|
Recruitment Status : Completed
First Posted : April 11, 2013
Results First Posted : October 22, 2015
Last Update Posted : October 22, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Application Site Discomfort Medical Device Discomfort||Drug: Bupivacaine with Epinephrine Drug: Normal Saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Control of Tourniquet Pain With an Axillary Ring of Subcutaneous Local Anesthetic|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Experimental: Injected with Bupivacaine
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.
Drug: Bupivacaine with Epinephrine
10-15 mL 0.25% Bupivicaine with epinephrine 1:200,000 subcutaneous axillary ring
Other Name: Marcaine, Exparel, Sensorcaine
Sham Comparator: Injected with saline
A subcutaneous axillary ring of 10 to 15 mL of normal saline will be injected in the arm 15 minutes prior to tourniquet inflation.
Drug: Normal Saline
Other Name: Placebo
- Time in Minutes That Tq Remained Inflated [ Time Frame: 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. ]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.
- Pain Score at Time of Tq Deflation [ Time Frame: 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 visual analog pain score (VAS) from 0 to 10 was assessed at the time of Tq deflation. 0 indicating no pain, and 10 indicating the worst possible pain. All participants requested deflation prior to the maximum allowable 60 minutes, Subjects were instructed to request deflation at the same degree of discomfort for each visit. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829399
|United States, North Carolina|
|University of North Carolina at Chapel Hill Medical Center|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Randall F Coombs, M.D.||University of NC at Chapel Hill Dept. of Anesthesiology|