Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Insertion Distance of Femoral Perineural Catheters in the Context of Major Knee Surgery.

This study has been completed.
Sponsor:
Information provided by:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT00726219
First received: July 29, 2008
Last updated: February 9, 2011
Last verified: June 2010
  Purpose

This study is designed to compare femoral perineural catheter insertion distances, in order to help determine which is the best for pain relief after knee surgery.

Hypothesis: the quality of the femoral nerve block will not be inferior if the catheter is inserted deeper (7cm compared to 3 cm)


Condition Intervention
Total Knee Arthroplasty
Other: Femoral perineural catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Influence of the Insertion Distance on Loss of Sensation Produced by Femoral Perineural Catheters in the Context of Major Knee Surgery.

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Sensory block assessment [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of pain relief [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Insertion distance of femoral catheter: 3cm
Other: Femoral perineural catheter
Comparison of 2 insertion distances (3 vs 7 cm) for a femoral perineural catheter in the context of major knee surgery.
2
Insertion distance of femoral catheter: 7cm
Other: Femoral perineural catheter
Comparison of 2 insertion distances (3 vs 7 cm) for a femoral perineural catheter in the context of major knee surgery.

Detailed Description:

Pain after knee surgery is reported as severe for 60% of patients, and is a major concern in both hospitalised and ambulatory surgery patients. Pain control is particularly important, as adequate analgesia allows rapid mobilisation of the operated knee and prevents complications related to immobility. Several methods have been proposed to treat this pain, the most promising being injection of local anesthetic close to the femoral nerve. The injection of local anesthetics around the femoral nerve reduces sensation from the knee and provides better pain relief after surgery than narcotic medication. To prolong the duration of the analgesia, a small catheter must be positioned next to the nerve. Through this catheter, small quantities of local anesthetics can be continuously delivered for several hours after surgery, effectively relieving the worst of the pain.

To date, the administration of local anesthetics through a catheter next to the femoral nerve has been shown to improve pain relief after knee replacement surgery. These pain relief benefits have resulted in faster recovery after total knee replacement. Until recently, catheter techniques were not frequently used due to technical difficulties encountered when attempting to find the femoral nerve, as well as difficulties related to catheter displacement after surgery. Due to recent improvements in nerve and catheter localisation, catheter installation has become easier, more precise and more reliable. However, the distance at which the catheter must be advanced next to the femoral nerve in order to provide the best pain relief remains unknown. Insertion distance could influence the initial quality and distribution of the freezing, its duration, or both. Therefore, this study is designed to compare two catheter insertion distances, in order to help determine which is best for pain relief after knee surgery.

Patients will be randomly assigned to the following groups:

  • Group 1: 3 cm insertion
  • Group 2: 7 cm insertion

The anesthesiologist will insert a catheter close to the femoral nerve, at the junction of the thigh and torso immediately before beginning of anesthesia for surgery. The usual medication will be used to make installation more comfortable. The exact location where the catheter will be put into place will be identified using an ultrasound machine. This device will allow the anesthesiologist to identify the various anatomical structures. A specially designed needle will be inserted next to the femoral nerve, and its position will be confirmed with a neurostimulator. Once the adequacy of needle position is confirmed, the anesthesiologist will introduce 3 cm(Group 1) or 7 cm (Group 2)of the catheter through the needle, and then will withdraw the needle. The catheter will be fixed in place to avoid displacement.

Patients will receive standard regional or general anesthesia for this type of surgery.

After surgery, pain will be assessed using a verbal numeric pain scale. A Patient Controlled Analgesia pump will be provided to the patients. In addition, all patients will receive local anesthetics through their femoral catheter for at least 24 hours after surgery, which will partially freeze the knee.

Patients will be asked to fill out a pain intensity measurement form using a 0-10 pain scale at 3, 6 and 24 hours after surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18 years or older undergoing major knee surgery.

Exclusion Criteria:

  • Coagulopathy
  • Pregnancy
  • Allergy to local anesthetics
  • Patient unable to consent
  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: NCT00726219

Locations
Canada, Quebec
CSSS Chicoutimi
Chicoutimi, Quebec, Canada, G7H 5H6
Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Stephan R Williams, MD, PhD Centre Hospitalier de l'Université de Montréal
  More Information

No publications provided

Responsible Party: Dr Stephan Williams, Centre Hospitalier de l'Université de Montréal
ClinicalTrials.gov Identifier: NCT00726219     History of Changes
Other Study ID Numbers: HD07.052
Study First Received: July 29, 2008
Last Updated: February 9, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Major
knee
surgery

ClinicalTrials.gov processed this record on November 27, 2014