search
Back to results

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

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bupivacaine 0.5%
Bupivacaine 0.5% + Epinephrine (1:200,000)
Sponsored by
Lalonde, Donald H., M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Bupivacaine, digital nerve block, epinephrine, duration of action, pain, touch, pressure, temperature

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Saint John Regional Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Ring Finger Nerve Block

Arm Description

Outcomes

Primary Outcome Measures

Time to return of pin-prick (pain) sensation

Secondary Outcome Measures

Full Information

First Posted
October 1, 2012
Last Updated
October 2, 2012
Sponsor
Lalonde, Donald H., M.D.
search

1. Study Identification

Unique Protocol Identification Number
NCT01698593
Brief Title
Bupivacaine Digital Blocks: How Long is the Pain Relief and Temperature Elevation?
Official Title
Bupivacaine Digital Blocks: How Long is the Pain Relief and Temperature Elevation?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lalonde, Donald H., M.D.

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Bupivacaine, digital nerve block, epinephrine, duration of action, pain, touch, pressure, temperature

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ring Finger Nerve Block
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.5%
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.5% + Epinephrine (1:200,000)
Primary Outcome Measure Information:
Title
Time to return of pin-prick (pain) sensation
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs