ClinicalTrials.gov
ClinicalTrials.gov Menu

Catheter-over Needle: Outpatient Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01522066
Recruitment Status : Unknown
Verified December 2014 by University of Alberta.
Recruitment status was:  Active, not recruiting
First Posted : January 31, 2012
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
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 or disease Intervention/treatment Phase
Local Anesthesia Analgesia Procedure: Perineural catheter Procedure: Single-shot block Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Postoperative pain levels [ Time Frame: 24 hours following surgery ]
    Pain levels at surgery site following surgery (up to 24 hours post-surgery) will be assessed.


Secondary Outcome Measures :
  1. Patient comfort at home [ Time Frame: Post-operative period (approx. 24 hrs following surgery) ]
    Patient pain levels and effects on daily living/activities will be assessed following surgery.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522066


Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Ban Tsui, MD, MSc University of Alberta

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
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014

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