Clinical trial NCT00726219: Insertion Distance of Femoral Perineural Catheters in the Context of Major Knee Surgery.
Official title: Influence of the Insertion Distance on Loss of Sensation Produced by Femoral Perineural Catheters in the Context of Major Knee Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Major
knee
surgery
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2008-07-31
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

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 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

Primary outcomes:
measure: Sensory block assessment
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Quality of pain relief
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Chicoutimi
country: Canada
facility: CSSS Chicoutimi
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Stephan R Williams, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: