Arthritis Clinical Trial
Official title:
Improving the Success Rate of Continuous Peripheral Nerve Blocks Using a Novel Coiled Catheter
Verified date | June 2012 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | Health Canada: Canada |
Study type | Interventional |
Major orthopaedic surgery is painful and requires safe and effective postoperative analgesic
therapy. The successful use of continuous peripheral nerve blocks provides sustained
analgesia while minimizing the need for opioid analgesics throughout the postoperative
period and avoiding the side effects associated with central neuraxial techniques. Excellent
analgesia can be maintained and opioid-related side effects avoided allowing improved
rehabilitation. However using existing methods a failure rate of >20% significantly limits
the analgesic benefits in a substantial proportion leading to uncontrolled pain and side
effects of opioid analgesics.
A major concern with the use of continuous peripheral nerve blocks is difficulty in
placement of the catheters close enough to the nerve to allow for effective local
anaesthetic spread and therefore analgesia. The benefit of ultrasound to precisely place
needles adjacent to nerves and increase efficacy of block success is undisputed. However
ultrasound is of less help in accurately placing catheters. Indeed the final position of the
catheter tip is not predictable and can be inadequate in 10%-50% of cases. The explanation
for that is the material in currently used catheters is stiff and designed to avoid kinking.
Unfortunately this same stiffness often leads to inadequate placement of the catheter tip.
We have developed a catheter which coils up as soon as it is advanced beyond the needle tip,
thus allowing the catheter tip to remain close to the initial needle tip position and
therefore the nerve. The aim of this prospective randomized double blind controlled study is
to determine the effectiveness of this new catheter in comparison with standard of care
methods for continuous femoral nerve block commonly used after total knee arthroplasty. The
primary outcome measure will be the incidence of catheter related block failure 24 hours
after surgery. Our hypothesis is that the coiled catheter will significantly improve the
efficacy of continuous femoral nerve block as compared to existing techniques.
Status | Completed |
Enrollment | 152 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Ability to provide informed consent, understanding of the possible local anaesthetic-related complications, and understanding of the study protocol. Exclusion Criteria: Any contraindication to peripheral nerve block, allergy to local anaesthetics, infection near the insertion site, ASA classification IV or V, pregnancy, chronic opioid analgesic therapy (>30mg morphine equivalent per day), coagulopathy, known hepatic or renal insufficiency, peripheral neuropathy and patient refusal. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centres, Holland Orthopedic and Arthritic Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre |
Canada,
Luyet C, Seiler R, Herrmann G, Hatch GM, Ross S, Eichenberger U. Newly designed, self-coiling catheters for regional anesthesia--an imaging study. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):171-6. doi: 10.1097/AAP.0b013e31820d431a. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Secondary block failure rate | The primary outcome measure will be the presence or absence of analgesia (loss of temperature sensation in the femoral nerve distribution) on postoperative day 1 at 24 hours after placement of the catheter. Secondary block failure rates are defined as presence of temperature sensation in the sensory distribution of the femoral nerve i.e.: anterior aspect of the thigh and anteromedial lower leg. |
24 hours after intervention (i.e. catheter placement) | No |
Secondary | Catheter placement | Technical difficulty of catheter placement: a. Number of attempts to place the catheter. b. lowest nerve stimulator output current at the final position of the catheter. Total time taken to place the catheter. Primary block failures as evaluated during the first 20 minutes after injection of Mepivacaine 1% through the catheters; defined as only partial or absent sensory or motor block in the sensory distribution of the femoral nerve as is: anterior aspect of the thigh and strength of quadriceps muscle. |
1 Minute after Catheter placement | No |
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