Catheter-over Needle: Outpatient Study
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: Local anesthetic delivery |
| 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 |
- 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.
- 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: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Catheter
Local anesthetic will be delivered through an indwelling perineural catheter
|
Procedure: Local anesthetic delivery
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
Local anesthetic will be delivered by the conventional, single-shot method.
|
Procedure: Local anesthetic delivery
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 |
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| Contact: Ban Tsui, MD, MSc | 780-407-8604 | btsui@ualberta.ca |
| Canada, Alberta | |
| University of Alberta Hospital | Recruiting |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Principal Investigator: Ban Tsui, MD, MSc | |
| Sub-Investigator: Gareth Corry, PhD | |
| Principal Investigator: | Ban Tsui, MD, MSc | University of Alberta |
More Information
No publications provided
| 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: | May 15, 2013 |
| 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 June 17, 2013