Coiled Catheters for Regional Anesthesia

NCT01290185 | Completed

• 1 other identifier: Luyet Coiled Catheters
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthritis

Keywords

Arthroplasty; Pharmacol Nerve Block

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Catheter placement

  1 Minute after Catheter placement

Study Arms (2)

Coiled Catheter

EXPERIMENTAL

Placement of the coiled catheter for continuous infusion of local anesthetics close to the femoral nerve: To place coiled catheters ab 18-gauge Tuohy needle (Sonoline Curl Catheter Set, Pajunk® Medizintechnologie GmbH, Geisingen, Germany) of 8 cm length is placed adjacent to the nerve by ultrasound guidance and nerve stimulator control. At this position and after injection of 5 ml dextrose 5% in water to dilate the space the coiled catheter is blindly advanced 2 cm through the needle and the final position verified with ultrasound.

Device: Placement of different catheters for continuous nerve block

Conventional stimulating Catheter

ACTIVE COMPARATOR

For the control group a conventional stimulating catheter is placed adjacent to the femoral nerve as follows: To place the simulating catheter an 18-gauge Tuhoy needle s placed adjacenit to the nerve by ultrasound guidance. At this position a stimulation catheter is introduced through the needle and stimulated with a decreasing current from 1 mA to 0.4 mA, with a pulse width 0.1ms to verify the appropriate motor response of the quadriceps muscle. The catheter is slowly advanced 3 cm beyond the needle tip under continuous electric stimulation using a current that is subsequently adapted according to the motor response achieved. If muscles twitches disappear during catheter placement at a current above 1 mA, either the catheter or the needle are manipulated until muscle twitches reappear.

Device: Placement of different catheters for continuous nerve block

Interventions

Placement of different catheters for continuous nerve block DEVICE

Placement different catheters adjacent to the femoral

Also known as: Sonoline Curl Catheter Set, Pajunk, StimuCath; Arrow International

Coiled Catheter; Conventional stimulating Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent, understanding of the possible local anaesthetic-related complications, and understanding of the study protocol.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centres, Holland Orthopedic and Arthritic Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• 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.

  PMID: 21270719 BACKGROUND

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Colin J McCartney, M.D.

  Sunnybrook Health Sciences Centres, Toronto

  STUDY DIRECTOR

• Cédric Luyet, M.D.

  Sunnybrook Health Sciences Centres, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 4, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

CA (1)