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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injected with Bupivacaine | Experimental | 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. |
|
| Injected with saline | Sham Comparator | A subcutaneous axillary ring of 10 to 15 mL of normal saline will be injected in the arm 15 minutes prior to tourniquet inflation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine with Epinephrine | Drug | 10-15 mL 0.25% Bupivicaine with epinephrine 1:200,000 subcutaneous axillary ring |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score at Time of Tq Deflation | 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. |
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Inclusion Criteria: Volunteers will be eligible for the study if they meet all of the below criteria;
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall F Coombs, M.D. | University of NC at Chapel Hill Dept. of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill Medical Center | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivacaine Ring 1st Visit, Saline Ring 2nd Visit | Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000 on the first visit and a subcutaneous axillary ring injection with saline on the second visit. |
| FG001 | Saline Ring 1st Visit, Bupivacaine Ring 2nd Visit | Participants received a subcutaneous axillary ring injection with normal saline on the first visit and a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000 on the second visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 |
| |||||||||||||
| Visit 2 (One Month Later) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine Ring 1st Visit, Saline Ring 2nd Visit | On the first visit, subcutaneous axillary ring of 10 to 15 ml of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation. On the second visit, a subcutaneous axillary ring of 10 to 15 ml of saline was injected 15 minutes prior to tourniquet inflation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | Minutes | 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. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bupivacaine Axillary Ring | Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randall F. Coombs, M.D. | Anesthesiology Department, University of NC at Chapel Hill | 919-966-5136 | rcoombs@aims.unc.edu |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D004837 | Epinephrine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Normal Saline | Drug |
|
|
| 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. |
| NOT COMPLETED |
|
| BG001 |
| Saline Ring 1st Visit, Bupivacaine Ring 2nd Visit |
On the first visit, a subcutaneous axillary ring of 10 to 15 mL of normal saline was injected 15 minutes prior to tourniquet inflation. On the second visit, a subcutaneous axillary ring of 10 to 15 ml of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Arm Dominance | Since clinical tourniquet application may be on the patients dominant arm or non-dominant arm, participants were stratified according to dominant or non-dominant arm in order to make the results of this study more generalisable. | Number | participants |
|
| OG001 | Saline Axillary Ring on 1st Visit (Control Group) | Participants received a subcutaneous axillary ring injection with normal saline. |
|
|
| Secondary | Pain Score at Time of Tq Deflation | 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. | Posted | Mean | 95% Confidence Interval | scores on a scale | 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. |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Saline Axillary Ring (Control Group) | Participants received a subcutaneous axillary ring injection with normal saline | 0 | 12 | 0 | 12 |
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| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |