Assessment of the additional effect of a peripheral pain management technique to regular PCA controlled intravenous morphine technique. Also the two peripheral pain management techniques will be compared: femoral nerve block technique and the intra-…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
VAS-pain and morphine useage after 24 hours postoperatively
Secondary outcome
Mobility variables (range or motion of the replaced knee joint, 3-metre walking
test), morphine related side-effects (gastro-intestinal (nausea, vomitis,
obstipation), neurological (allertness), miction, itching. Clinical scores:
WOMAC, Knee society score, SF-36, satisfaction.
Background summary
Until now, intravenous morphine is still main-stay in pain management after
knee total arthroplasty. Given the systemic character of this technique and the
well-known morphine side-effects, the pain reduction and rehabilitation are
still not yet optimal. Developments in peripheral (additive) pain treatment
techniques take a flight. The nervus femoralis block technique with a local
anaesthetic has the advantage of loko-regional pain management. The
intra-articular infiltration technique with a local anaesthetic blocks the pain
at it's source: tissue damage caused by the operative intervention. Betere pain
management, swifter mobilisation and less morphine associated side-effects as a
result.
Study objective
Assessment of the additional effect of a peripheral pain management technique
to regular PCA controlled intravenous morphine technique. Also the two
peripheral pain management techniques will be compared: femoral nerve block
technique and the intra-articular infiltration technique with a known local
anaesthetic.
Study design
In a randomised double blind placebo controlled trial set-up patients with
arthritis of the knee undergo a total knee operation. These patients will
recieve postoperative basic pain treatment by means of intravenous morphine
(2,0mg/ml) according to the PCA (patient controlled analgesia) principle. All
patients will recieve a femoral nerve catheter (in the groin) and a
intraarticular catheter (in the knee). The groups will be created: group 1
(continuous local anaesthetic via a groin catheter and placebo via the
intraarticular catheter), group 2 (continuous placebo via a groin catheter -
and local anaesthetic via intraarticular catheter)en group 3 (control group)
(continuous placebo via a groin catheter - and via intraarticulaire catheter).
levobupivacaine 0.25% will be used as local anaesthetic and saline in the same
volume quantities will be used as placebo 24 hours postoperative. VAS for pain,
degree of mobility and (morphine related) side effects are scored
postoperatively.
Intervention
peripheral pain treatment technique with a known local anaesthetic by means of
the femoral nerve block technique or the intraarticular infiltration technique
of the knee by means of local infusion with catheters after total knee
replacement procedures.
Study burden and risks
Low. Femoral catherers are introduced before spinal anaesthesia is given,
thereby insuring effectiveness and securing optimal placement. The patient can
experience some inconvenience of this. The intraarticular catheter will be left
behind during closure of the wound. Both catheters will be removed 24-hours
postoperatively along with the wound drain before staring exercising.
Groot Weezenland 20
8011 JW Zwolle
Nederland
Groot Weezenland 20
8011 JW Zwolle
Nederland
Listed location countries
Age
Inclusion criteria
Symptomatic osteoarthritis of the knee,
Exclusion criteria
Other orthopaedic comorbidity inhibiting normal rehabilitation, contra's concerning spinal anaesthesia, inability performing in a group, > 85 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 | NL22448.075.08 |