Arthroplasty, Replacement, Knee Clinical Trial
Official title:
Comparison of Ropivacaine With or Without Fentanyl in Spinal Anaesthesia for Lower Limb Surgeries
There has been a wide variety of use of anaesthetic agents along with adjuncts during subarachnoid block. The quest for attaining adequate analgesia and anaesthesia has always been shadowed by the concurrent deleterious effect of the anaesthetic agent. Ropivacaine as an anesthetic agent has proven to meet the desired goals of anaesthesia while minimizing the potential side effects. The addition of different adjuncts has shown to enhance the analgesic property, prolong the duration of sensory blockade and decrease the dose related adverse effects of the local anaesthetics. Fentanyl in this regards has also shown some promising effects. Thus we compare the use of ropivcaine as a single agent versus ropivacaine along with an adjunct (Fentanyl) to attain the desired anesthetic effect while minimizing the associated side effects.
Spinal anaesthesia has been a widely used mode of anaesthesia for lower abdominal and
extremity surgeries. It blunts the "stress response" to surgery, decreases intraoperative
blood loss, lowers the incidence of postoperative thromboembolic events, and decreases the
morbidity in high-risk surgical patients. It serves as a useful method to extend analgesia
into the postoperative period, where its use has been shown to provide better analgesia than
parenteral opioids. In order to improve further and understand safety issues as well as the
clinical use of spinal anesthesia, new local anesthetics and analgesic additives are being
investigated for different application. With patient safety and comfort being the ultimate
goal of any health practice, one must keep in mind about the side effects and related
concerns of spinal anesthesia while achieving the desired level of anaesthesia and analgesia.
Adequate anesthesia and analgesia during and post-surgery along with early ambulation and
discharge seems to be the perfect recipe for the conduction of spinal anaesthesia in the
current practice. Ropivacaine is one local anesthetic that could have the potential in this
area. Ropivacaine is an amide local anesthetic with properties similar to bupivacaine
producing similar sensory block at equipotent doses, but with a shorter duration of motor
block. Thus, ropivacaine has a greater degree of motor sensory differentiation, which could
be useful when motor blockade is undesirable. Ropivacaine blocks nerve fibers involved in
pain transmission (A∂and C fibers) to a greater degree than those controlling motor function
(Aβ fibers).Blockade of Aα and Aβ is slow and hence produces lesser motor blockade than
bupivacaine. Though 40-50% less potent than bupivacaine, ropivacaine in an equipotent ratio
of 1.5:1 produces results in a similar clinical profile with good preservation of motor
function. Hence, its shorter duration, faster recovery of motor function, lower toxicity
profile, and minimal hemodynamic alterations have been identified as a potential benefit for
surgery of intermediate duration as well as for ambulatory surgery.
Though the use of bupivacaine is widespread, ropivacaine in the recent times has been used as
a spinal anaesthetic agent and evaluated in many procedures because of its equivalent spinal
anaesthetic effect and its lower risk of neurotoxicity and cardiotoxicity, compared with
bupivacaine. In addition, there have been reports of fatal cardiovascular toxicity following
use of bupivacaine in regional anesthesia.
Subarachnoid opioids with local anesthetics have become a well-accepted practice in spinal
anesthesia for surgical procedures. Several combinations of local anesthetics such as
lidocaine, bupivacaine, or ropivacaine, and opioids such as fentanyl have been reported for a
variety of surgical procedures. The addition of small-dose fentanyl (10-25 μg) intrathecally
to local anesthetics during spinal anesthesia has been shown to enhance duration of sensory
analgesia.The addition of adjuvants to ropivacaine has shown to improve the quality of
intra-operative and postoperative analgesia without compromising its benefits such as early
mobilization and early voiding. Parlow et al. established the fact that hypobaricity
influenced the extent of subarachnoid block and explained high cephalic levels of sensory
block when fentanyl was added to isobaric local anesthetic solution.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
Recruiting |
NCT05002387 -
Diagnostic Knee Needle Arthroscopy in Predicting Unicompartmental Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT06080763 -
Biomechanics and Clinical Outcomes in Responders and Non-Responders
|
||
Completed |
NCT03008967 -
A Study of Patients Undergoing Total Knee and Hip Arthroplasty at a Regional Hospital in Denmark
|
N/A | |
Withdrawn |
NCT02255877 -
ZIPS Study - Zip Incision Approximation vs. STAPLE
|
Phase 4 | |
Completed |
NCT02642731 -
Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty
|
N/A | |
Completed |
NCT02525588 -
Polyethylene Wear Study on the Triathlon Total Knee Prosthesis
|
N/A | |
Completed |
NCT01799772 -
The Feasibility of a Comprehensive Behavioral Intervention in Patient Post TKA
|
Phase 1/Phase 2 | |
Completed |
NCT02520531 -
Scorpio Posterior Stabilised (PS) vs Scorpio NRG ("Energize") PS - Total Knee Arthroplasty
|
N/A | |
Completed |
NCT03183856 -
Comparison of Ambulatory and Functional Improvement by Morning Walk
|
N/A | |
Completed |
NCT03569397 -
Music Therapy Versus Control for Total Knee Arthroplasty
|
N/A | |
Terminated |
NCT02711592 -
Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: a Pilot Study
|
N/A | |
Completed |
NCT03145493 -
Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid
|
N/A | |
Terminated |
NCT05602701 -
Preoperative Prediction of Postoperative Physical Function
|
||
Recruiting |
NCT03570944 -
Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol (POWER2)
|
||
Completed |
NCT02773537 -
Motor-Sparing Peripheral Nerve Blockade Facilitates Mobility Post Total Knee Arthroplasty: A Randomized Controlled Trial
|
N/A | |
Withdrawn |
NCT02553122 -
The Combined Efficacy of Evicel and Tranexamic Acid on Total Knee Arthroplasty
|
Phase 3 | |
Recruiting |
NCT02385383 -
An Intravenous Iron Based Protocol for Preoperative Anaemia in Hip and Knee Surgery - An Observational Study
|
N/A | |
Terminated |
NCT02155712 -
Triathlon Tritanium Knee Outcomes Study
|
N/A | |
Completed |
NCT02121392 -
Epidural Catheter With or Without Adductor Canal Nerve Block for Postoperative Analgesia Following Total Knee Arthroplasty
|
N/A |