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

NCT01698593 | Completed

• 1 other identifier: RS#2009-1356
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Bupivacaine; digital nerve block; epinephrine; duration of action; pain; touch; pressure; temperature

Outcome Measures

Primary Outcomes (1)

• Time to return of pin-prick (pain) sensation

  24 hours

Study Arms (1)

Ring Finger Nerve Block

ACTIVE COMPARATOR

Drug: Bupivacaine 0.5%; Drug: Bupivacaine 0.5% + Epinephrine (1:200,000)

Interventions

Bupivacaine 0.5% DRUG

Ring Finger Nerve Block

Bupivacaine 0.5% + Epinephrine (1:200,000) DRUG

Ring Finger Nerve Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult volunteer

You may not qualify if:

• Under the age of majority
• Unable to give consent
• Pregnancy
• Diabetes
• Allergy to local anesthetic
• Prior finger surgery
• Preexisting digital vascular ischemia

Sponsors & Collaborators

• Lalonde, Donald H., M.D.: lead

Study Sites (1)

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 3, 2012
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 3, 2012

Record last verified: 2012-10

Locations

CA (1)