Bupivacaine Digital Blocks: How Long is the Pain Relief and Temperature Elevation?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lalonde, Donald H., M.D.
ClinicalTrials.gov Identifier:
NCT01698593
First received: October 1, 2012
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

No one knows how long bupivacaine finger blocks last. Many use bupivacaine with and without epinephrine, but no one knows how the epinephrine affects the duration of the block. We also don't know how long the pain part of the block lasts, which is what counts.

The goal of the study is to determine the duration of action of bupivacaine digital nerve blocks (with and without epinephrine) on finger temperature and the sensory modalities of pain, touch, and pressure. 2 ml of bupivacaine 0.5% with and without epinephrine will be injected at the base of each ring finger on the palm surface. At the end of 1 hr, 6 hrs, 12 hrs, 14 hrs and each additional hour, patients will use an insulin lancet to measure pain, the Semmes Weinstein monofilament test to measure light touch and pressure and a body surface thermometer to measure finger temperature. The time for the finger to return to normal sensation and temperature will be measured.


Condition Intervention
Pain
Drug: Bupivacaine 0.5%
Drug: Bupivacaine 0.5% + Epinephrine (1:200,000)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Bupivacaine Digital Blocks: How Long is the Pain Relief and Temperature Elevation?

Resource links provided by NLM:


Further study details as provided by Lalonde, Donald H., M.D.:

Primary Outcome Measures:
  • Time to return of pin-prick (pain) sensation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: July 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ring Finger Nerve Block Drug: Bupivacaine 0.5% Drug: Bupivacaine 0.5% + Epinephrine (1:200,000)

Detailed Description:

Lidocaine finger blocks have been shown to provide analgesia for nearly 5 hours without epinephrine and approximately 10 hours with epinephrine - essentially doubling its duration.1,2 The analgesic effect of epinephrine on the duration of bupivacaine finger blocks remains unknown.

Bupivacaine finger injection provides a much longer duration of action than lidocaine. Previous studies have shown the duration of action to be as long as 24.9 hours.1 In the senior author's experience, however, patients who get bupivacaine blocks start asking for pain medication as early as 7 hours after the block. Is it possible that the pain blocking effect of bupivacaine has a different duration than the touch and pressure effects? The answer to this question also remains unknown.

The third unknown question about bupivacaine digital blocks is their effect on fingertip temperature. It has been shown that lidocaine wrist blocks increase temperature in finger tips, and this has been postulated to be potentially helpful in frostbite to provide pain relief and hyperemia.3 Previous studies have shown bupivacaine to exhibit vasodilatory properties at clinical concentrations of injection.4-7 Does bupivacaine provide increased warmth to the finger tip? How long does it last?

The goals of this study are three fold: 1.) To determine what effect epinephrine has on the duration of bupivacaine finger block anesthesia. 2.) To assess the duration of action of bupivacaine with and without epinephrine on the digital sensory modalities of pain, touch and pressure, and 3.) To assess the finger tip temperature changes that result from bupivacaine digital blocks with and without epinephrine.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult volunteer

Exclusion Criteria:

  • Under the age of majority
  • Unable to give consent
  • Pregnancy
  • Diabetes
  • Allergy to local anesthetic
  • Prior finger surgery
  • Preexisting digital vascular ischemia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698593

Locations
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Sponsors and Collaborators
Lalonde, Donald H., M.D.
  More Information

No publications provided

Responsible Party: Lalonde, Donald H., M.D.
ClinicalTrials.gov Identifier: NCT01698593     History of Changes
Other Study ID Numbers: RS#2009-1356
Study First Received: October 1, 2012
Last Updated: October 2, 2012
Health Authority: Canada: Health Canada

Keywords provided by Lalonde, Donald H., M.D.:
Bupivacaine
digital nerve block
epinephrine
duration of action
pain
touch
pressure
temperature

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms
Epinephrine
Epinephryl borate
Bupivacaine
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014