Total Knee Arthroplasty Clinical Trial
Official title:
Influence of the Insertion Distance on Loss of Sensation Produced by Femoral Perineural Catheters in the Context of Major Knee Surgery.
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)
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03542981 -
Interferential Current Therapy After Total Knee Arthroplasty
|
N/A | |
Recruiting |
NCT04458480 -
Effect of Fast Inpatient Rehabilitation After TKA
|
||
Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
Recruiting |
NCT06061367 -
Muscles Strength and Gait Parameteres After TKA
|
||
Recruiting |
NCT05391828 -
Persona MC vs PS RCT With ROSA
|
N/A | |
Active, not recruiting |
NCT04850300 -
Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses
|
Phase 3 | |
Completed |
NCT05635916 -
Trial of Liposomal Bupivacaine for TKA
|
Phase 4 | |
Enrolling by invitation |
NCT05130216 -
Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
|
||
Withdrawn |
NCT02495805 -
Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty
|
N/A | |
Completed |
NCT03206554 -
Local Infiltration Analgesia in Total Knee Arthroplasty
|
Phase 2 | |
Completed |
NCT01616836 -
Optimizing Pain and Rehabilitation After Knee Arthroplasty
|
Phase 3 | |
Withdrawn |
NCT01511211 -
Duration of Leg Nerve Blocks With Dexamethasone Added to Local Anesthetic
|
Phase 4 | |
Not yet recruiting |
NCT00958945 -
Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements
|
N/A | |
Completed |
NCT00985920 -
Topical Tranexamic Acid for Total Knee Arthroplasty
|
Phase 4 | |
Completed |
NCT00761956 -
A Study to Compare the NexGen CR and CR-Flex Knee Implants
|
N/A | |
Completed |
NCT03289247 -
Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty
|
N/A | |
Terminated |
NCT03316118 -
US Guided GNB vs Saline Injection for TKA
|
Phase 4 | |
Recruiting |
NCT05962970 -
Continuous Adductor Canal Block in Fast Track Total Knee Arthroplasty
|
N/A | |
Completed |
NCT03317834 -
Navio With Total Knee Arthroplasty
|
||
Enrolling by invitation |
NCT06188091 -
Joint Movement to Increase Range of Motion in Knee Joint After Primary Total Knee Arthroplasty
|
N/A |