Catheter-over Needle: Outpatient Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01522066
First received: January 26, 2012
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

An alternative to general anesthesia - which puts a patient completely to sleep - is regional anesthesia, where local anesthetic is injected under the skin to freeze or 'block' a nerve or set of nerves. This method allows a patient to be awake during surgery and avoids any unpleasant after-effects of general anesthetic. A regional block is normally performed by inserting a needle under the skin so that the needle tip is near the nerve to be blocked, followed by injection of a single shot of enough local anesthetic to block any sensation that the nerve normally provides. Although regional nerve blocks provide pain relief during a surgical procedure, they eventually wear off, occasionally leaving the patient to contend with localized pain in the part of the body that was operated on. In these cases, over-the-counter painkillers like Tylenol or Advil may not be strong enough to completely take away the pain. We believe that, instead of giving a single shot of anesthetic, patients can be fitted with a catheter - a thin, flexible tube - that can be used to deliver one dose of local anesthetic to block the nerve before surgery and which could also be used to deliver a second dose of anesthetic just prior to discharge from the hospital. This way, the patient still only receives one needle poke, but their pain can be better managed following surgery. Our study will compare the post-nerve block pain profiles of individuals who have received a single-shot injection of local anesthetic versus those who have received two doses via the catheter delivery method.


Condition Intervention
Local Anesthesia
Analgesia
Procedure: Perineural catheter
Procedure: Single-shot block

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comparison of the Effectiveness of Single-shot Local Anesthetic Delivery Versus Double-shot Local Anesthetic Delivery Via a Perineural Catheter

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Postoperative pain levels [ Time Frame: 24 hours following surgery ] [ Designated as safety issue: No ]
    Pain levels at surgery site following surgery (up to 24 hours post-surgery) will be assessed.


Secondary Outcome Measures:
  • Patient comfort at home [ Time Frame: Post-operative period (approx. 24 hrs following surgery) ] [ Designated as safety issue: No ]
    Patient pain levels and effects on daily living/activities will be assessed following surgery.


Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Perineural catheter
Local anesthetic will be delivered through an indwelling perineural catheter
Procedure: Perineural catheter
Patients in the experimental group will receive a single dose of local anesthetic though an indwelling catheter both before and after surgery.
Active Comparator: Single-shot block
Local anesthetic will be delivered by the conventional, single-shot method.
Procedure: Single-shot block
Patients in the control group will receive a single shot of local anesthetic, in standard fashion, before surgery.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (> 18 yrs)
  • Scheduled for surgery that requires peripheral nerve blockade

Exclusion Criteria:

  • Failure to provide informed consent
  • Allergy to local anesthetic
  • Neurological pathology and/or deficit in the block region
  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: NCT01522066

Contacts
Contact: Ban Tsui, MD, MSc 780-407-8604 btsui@ualberta.ca

Locations
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Principal Investigator: Ban Tsui, MD, MSc         
Sub-Investigator: Gareth Corry, PhD         
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Ban Tsui, MD, MSc University of Alberta
  More Information

No publications provided by University of Alberta

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01522066     History of Changes
Other Study ID Numbers: Pro000027421
Study First Received: January 26, 2012
Last Updated: January 28, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014