The aim of this clinical study is to investigate whether a combination of sciatic nerve blockade (single shot or continuous blockade) with continuous regional blockade of the femoral nerve will improve short and long term functional outcome as well…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reaching of discharge criteria (90 degree flexion of the knee, no infection,
pain on the visual analogue scale (VAS) lower than 4 (scale 0-10)
Secondary outcome
1. functional results at discharge and after 6 weeks and one year after the
operation, 2. Analgesic consumption: use of morphine and tramadol, pain
measured by VAS postoperatively on day 0, 1, 2 and 3 during rest and movement,
respectively, 3. Postoperative nausea and vomiting (PONV, 0: absence, 1: mild,
2: severe), 4. Effect of removing catheters on functional aspects (loss of
functional capacity after removing catheters), 5. Patient overall satisfaction
(measured using the Oxford knee questionnaire, a score with good reliability,
content validity and construct validity in patients subjected to
TKA15;16)Patient satisfaction with regional blockade procedure (school marks),
6. Time necessary to place catheters, 7. Amperage of stimulation of motor
response, 8. Onset of motor and sensory block
Background summary
A Clinical Pathway for patients subjected to knee arthroplasty has been
introduced in the Academic Medical Center Amsterdam AMC. In a multidisciplinary
group including every department contributing to the clinical pathways of these
patients, all aspects of pre-, intra-, and postoperative care including
facilities at home have been discussed. Regarding anesthesiologic care, one
major point is the best possible postoperative pain management and the
influence of postoperative pain on long-term functional outcome. This topic
shall be addressed in the current study.
Study objective
The aim of this clinical study is to investigate whether a combination of
sciatic nerve blockade (single shot or continuous blockade) with continuous
regional blockade of the femoral nerve will improve short and long term
functional outcome as well as patient satisfaction after total knee
arthroplasty.
Study design
single center, prospective, randomized controlled study.
Intervention
Group A: ultrasound guided introduction of a stimulated femoral nerve catheter
Intraoperative pain therapy: levo-bupivacaine 0.375% 20 ml followed by
continuous infusion of levo-bupivacaine 0.125% 10 ml/h starting 45 min after
first injection
Postoperatively: levo-bupivacaine 0.125% patient controlled analgesia via the
catheter (5 ml bolus, 30 min lock-out, basal rate: 6 ml/h)
Group B: ultrasound guided introduction of a stimulated femoral nerve catheter
Intraoperatively: levo-bupivacaine 0.375% 20 ml followed by continuous infusion
of levo-bupivacaine 0.125% 10 ml/h starting 45 min after first injection
N. ischiadicus single shot, 20 ml levo-bupivacaine 0.375 %
Postoperatively: levo-bupivacaine 0.125% patient controlled analgesia via the
catheter (5 ml bolus, 30 min lock-out, basal rate: 6 ml/h)
Group C: ultrasound guided introduction of a stimulated femoral nerve catheter
Intraoperatively: levo-bupivacaine 0.375% 20 ml followed by continuous infusion
of levo-bupivacaine 0.125% 10 ml/h starting 45 min after first injection
Introduction of a stimulating catheter along sciatic nerve, 20 ml
levo-bupivacaine 0.375 % via the catheter
Postoperatively: levo-bupivacaine 0.125% patient controlled analgesia via the
femoralis catheter (5 ml bolus, 30 min lock-out, basal rate: 6 ml/h),
continuous infusion of levo-bupivacaine 0.125% 10 ml/h via sciatic nerve
catheter.
Study burden and risks
No additional burden is expected as clinically used routine pain management
strategies are compared with each other
Meibergdreef 9
1100 DD Amsterdam
NL
Meibergdreef 9
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Informed consent, American Society of Anesthesiologists (ASA) classification I to III, age older than 18 years
Exclusion criteria
no informed consent, ASA classification IV or V, infection near the insertion side, coagulation disorder, allergy to local anesthetics, pre-existing neurologic dysfunction, prior vascular surgery near the insertion side, inability to understand the patient controlled analgesia device, pregnancy or lactation period, known hepatic or renal insufficiency, age < 18 years.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL20054.018.07 |