Knee Osteoarthritis Clinical Trial
Official title:
Psoas Sciatic Blockade Could be a Sole Anaesthetic Technique for Total Knee Arthroplasty
Objectives: To compare the efficacy of continuous combined psoas sciatic block as a sole
anaesthetic technique with conventional combined spinal epidural anesthesia for patients
undergoing total knee arthroplasty.
Subjects and Method: Eighty patients ASA (American society of anaesthesiologists
classification) I to III with age range from 50 to 65 years old and scheduled for total knee
replacement were included in the study. Subjects were divided into two groups; the first
group (Pso/sci) received ultrasound guided with the use of nerve locator continuous psoas
sciatic block and the second group (CSE) received combined spinal epidural anesthesia. Onset
of sensory and motor block time, hemodynamic changes, contra-lateral spread, first time need
for analgesia, incidence of complications, and patient and surgeon satisfactions were
recorded.
After approval of the ethics committee, department of anaesthesia, Menoufia university and
written informed consent, 80 patients undergoing unilateral total knee arthroplasty were
randomly allocated into two groups. The first group (40 patients) received continuous psoas
compartment block combined with continuous sciatic block (Pso/Sci group) and the second group
(40 patients) received combined spinal epidural anaesthesia (CSE group). All patients were
between 50 and 65 years old with an American society of anaesthesiologists classification
(ASA status) of I to III. Patients' exclusion criteria included contraindication of regional
anesthesia, bleeding disorders, localized infection, neurological deficit, substance
dependence, and uncooperative patients. Upon arrival to the operative theater patients were
attached to the standard monitoring and an intravenous cannula was inserted. All patients
received 1 - 2 mg midazolam for sedation before the blocks.
Sciatic nerve blockade:
The block was done under complete aseptic technique. The patient was positioned in the
lateral recumbent position with the operative side up and the hips and knees were flexed. The
greater trochanter, posterior superior iliac spine and sacral hiatus were palpated and
marked. Curvilinear low frequency U/S probe 2-5 MHz, (Sonosite, M-Turbo, Sonosite Inc., USA)
was used for scanning. The probe was placed transversely in the middle of the line connecting
the greater trochanter and sacral hiatus. The hip joint and the ischial spine were seen as
hyperechoic lines in the lateral and medial sides respectively and the sciatic nerve was
appeared as a triangular or flattened hyperechoic structure under the gluteus maximus. Local
infiltration with 1 ml lidocaine 2% with 27-gauge needle was done before introducing the 100
mm 18 gauge sterile insulating pajunk needle (PAJUNK, PlexoLong, Germany) for the block.
The pajunk needle was connected to a nerve stimulator (Plexygon, Vygon Italia, Padua, Italy)
with 0.8 mA initial current and inserted out of plane reaching the sciatic nerve until
eliciting either planter flexion or dorsiflexion with reduced current output up to 0.2 mA. A
mixture of 15 ml lidocaine 1% and 15 ml bupivacaine 0.25% were injected around the sciatic
nerve. A multi-perforated reinforced catheter was inserted through the needle and advanced 5
cm distal to the needle tip to provide continuous infusion. The needle was removed and the
catheter was fixed to the skin.
Psoas compartment blockade:
The block was done under complete aseptic technique. The patient was positioned in the
lateral recumbent position with the operative side upper most and hip and knee were flexed.
L4-5 space was identified and marked by a line passing between the iliac crest and vertebral
column. The puncture point for the block was marked 5 cm lateral to the L4-5 space within the
drawn line. Using curvilinear low frequency U/S probe 2-5 MHz, (Sonosite, M-Turbo, Sonosite
Inc., USA) the area was scanned longitudinally starting from the sacrum and moving cranially
to identify the 4th transverse process then turned transversally in a rocking manner
laterally to the end of the transverse process. The skin at the site of entry was infiltrated
with 1 ml lidocaine 2% using 27-gauge needle. A 100 mm 18 gauge insulating pajunk needle
(PAJUNK, PlexoLong, Germany) connecting to a nerve stimulator (Plexygon, Vygon Italia, Padua,
Italy) with 0.8 mA initial current was advanced from medial to lateral proximal to the
transverse process of L4 then advanced caudally to it until eliciting the quadriceps femoris
contraction. When the contraction was persisted with reduced current down to 0.2 mA, a
mixture of 20 ml lidocaine 1% and 20 ml bupivacaine 0.25% were injected after repeated
negative aspiration. A multi-perforated reinforced catheter was inserted through the pajunk
needle and was advanced 5 cm distal to the needle tip. The needle was removed and catheter
was fixed to the skin.
Combined spinal epidural block:
The patient was in the sitting position, L3-4 space was marked then the area was sterilized
and draped. Local anaesthetic (LA) was applied in the track by 27 gauge needle with 5 ml
Lidocaine 1%. With portex combined spinal epidural kit needle through needle (PORTEX, Smiths
Medical ASD, Inc., USA), the epidural space was detected by loss of resistance technique with
saline then 27 gauge 120 mm pencil point spinal needle passed through the epidural needle
till perforating the dura and observing the cerebrospinal fluid, 2.5 ml (12.5 mg) of heavy
bupivacaine 0.5% (Bupivacaine hydrochloride 0.5%, 5mg/ml, AstraZeneca) was injected. The
needle was removed and the epidural catheter was advanced 4 cm distal to the needle tip and
fixed to the skin.
After block was done all the patients returned back to the supine position, the sensory block
was assessed by cold perception using ice backs and the motor block was assessed by Bromage
scale (3=no flexion of hip, knee and foot; 2=no flexion of hip and knee with foot flexion;
1=no flexion of hip with flexion of knee and foot; 0=full flexion of hip, knee and foot).
Sensory and motor blocks were assessed every 10 minutes for 3 times. Bilateral assessment was
done to detect epidural spread of local anesthetics. Failure to establish adequate sensory
and motor blocks after 30 minutes, a failed block was considered and general anesthesia was
induced if there were no contraindications and the patient was excluded from the study.
In both groups, the time taken to finish the block was recorded. The onset of sensory and
motor blocks were recorded which was defined as the time from finishing the blockade to the
occurrence of the block.
In the post-operative period, the duration of the sensory block for both groups was recorded
which was defined as the time between the onset of the block and the asking for first
analgesia. Once the patient experienced pain (VAS ≥ 3), a bolus of 5 ml Lidocaine 2 % was
injected in both catheters in (pso/sci) group and epidural catheter in (CSE) group then
continuous LA infusion was followed using a solution of 0.125 % Bupivacaine in a rate of 7-10
ml/hour according to the patient response. Heart rate and blood pressure were recorded every
5 minutes all through the procedures; bradycardia and hypotension were considered if the
heart rate and the mean blood pressure were 30% below the starting baseline. Bradycardia was
treated by IV 0.5 mg atropine and hypotension was managed by 10- 15 mg IV ephedrine. Intra-
and post-operative side effects like bradycardia, hypotension, nausea and vomiting were
recorded. Age, gender, weight, ASA class and duration of surgery (time from skin incision
until skin closure) were recorded. Data was analyzed using SSPS software 12.0 (SSPS Inc.,
Chicago, IL, USA) and represented as mean ± standard deviation and p value less than 0.05 was
considered to be statistically significant.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04651673 -
Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
|
||
Completed |
NCT05677399 -
Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.
|
N/A | |
Active, not recruiting |
NCT04043819 -
Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis
|
Phase 1 | |
Recruiting |
NCT06000410 -
A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee
|
Phase 3 | |
Completed |
NCT05014542 -
Needling Techniques for Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05892133 -
Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
|
N/A | |
Recruiting |
NCT05528965 -
Parallel Versus Perpendicular Technique for Genicular Radiofrequency
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Active, not recruiting |
NCT02003976 -
A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
|
N/A | |
Active, not recruiting |
NCT04017533 -
Stability of Uncemented Medially Stabilized TKA
|
N/A | |
Completed |
NCT04779164 -
The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT04006314 -
Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05423587 -
Genicular Artery Embolisation for Knee Osteoarthritis II
|
N/A | |
Enrolling by invitation |
NCT04145401 -
Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
|
||
Active, not recruiting |
NCT03781843 -
Effects of Genicular Nerve Block in Knee Osteoarthritis
|
N/A | |
Completed |
NCT05974501 -
Pre vs Post Block in Total Knee Arthroplasty (TKA)
|
Phase 4 | |
Completed |
NCT05324163 -
Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis
|
Phase 3 | |
Completed |
NCT05529914 -
Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05693493 -
Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?
|
N/A | |
Not yet recruiting |
NCT05510648 -
Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis
|
N/A |