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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

October 1, 2012
October 2, 2012
July 2009
July 2010   (final data collection date for primary outcome measure)
Time to return of pin-prick (pain) sensation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01698593 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Bupivacaine Digital Blocks: How Long is the Pain Relief and Temperature Elevation?
Bupivacaine Digital Blocks: How Long is the Pain Relief and Temperature Elevation?

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Pain
  • Drug: Bupivacaine 0.5%
  • Drug: Bupivacaine 0.5% + Epinephrine (1:200,000)
Active Comparator: Ring Finger Nerve Block
Interventions:
  • Drug: Bupivacaine 0.5%
  • Drug: Bupivacaine 0.5% + Epinephrine (1:200,000)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01698593
RS#2009-1356
Not Provided
Lalonde, Donald H., M.D.
Lalonde, Donald H., M.D.
Not Provided
Not Provided
Lalonde, Donald H., M.D.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP