Control of Tourniquet Pain With an Axillary Ring of Subcutaneous Local Anesthetic

• ClinicalTrials.gov Identifier: NCT01829399
• Recruitment Status: Completed
• First Posted: April 11, 2013
• Results First Posted: October 22, 2015
• Last Update Posted: October 22, 2015
• Sponsor: University of North Carolina, Chapel Hill
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

Brief 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 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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria: Volunteers will be eligible for the study if they meet all of the below criteria;

• American Society of Anesthesiologists (ASA) classification I or II
• 18 years of age to a maximum of 70 years of age

Exclusion criteria:

• Pre-existing parasthesia or neuropathy of any kind
• History of excessive alcohol consumption (> three drinks per night)
• Take analgesics on a regular basis
• History of any drug abuse
• Baseline systolic blood pressure ≥ 150
• Baseline diastolic blood pressure ≥ 85
• BMI ≥ 30 Pregnancy Allergic reaction to local anesthetic

Contacts and Locations

Locations

United States, North Carolina

University of North Carolina at Chapel Hill Medical Center

Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: Randall F Coombs, M.D.; University of NC at Chapel Hill Dept. of Anesthesiology

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT01829399
• Other Study ID Numbers: 12-2373
• First Posted: April 11, 2013
• Results First Posted: October 22, 2015
• Last Update Posted: October 22, 2015
• Last Verified: October 2015

Keywords provided by University of North Carolina, Chapel Hill:

Tourniquet pain; Subcutaneous axillary local anesthetic; ability to tolerate tourniquet discomfort.

Additional relevant MeSH terms:

Epinephrine; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic beta-Agonists; Bronchodilator Agents; Autonomic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Sympathomimetics; Vasoconstrictor Agents