The purpose of this study is to evaluate whether there are differences in duration and intensity at a femoral nerve block with ropivacaine Klaris standard 30ml 0.2% with and without addition of buprenorphine (Temgesic ®) 0.3 mg buprenorphine…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
anaesthesie, pijnbehandeling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Does 0.3 mg of buprenorphine as an additive in femoral nerve blockade prolongs
analgesia?
Secondary outcome
1. Does buprenorphine 0.3 mg as an additive in nerve femoralisblokkade give a
reduction of postoperative opiate use the first 24-48 hours postoperatively?
2. Does buprenorphine 0.3 mg subcutaneously given the same effect as if close
to nerve femoralisblokkade administered?
3. Does buprenorphine 0.3 mg as an additive in nerve femoralisblokkade
increase nausea during the first 24 hours postoperatively.
4. Does buprenorphine 0.3 mg as an additive in nerve femoralisblokkade give a
reduction of VAS score postoperatively?
5. Does buprenorphine 0.3 mg as an additive in a patient with nervus
femoralisblokkade the first 24 hours postoperatively better mobilization
(definedd as 30mtr walking)?
6. Does buprenorphine 0.3 mg as an additive in nerve femoralisblokkade produce
a higher quality of life (QOL) score the first 24 hours postoperatively?
7. Does buprenorphine 0.3 mg as an additive prolonged nerve femoralisblokkade
analgesia compared with a nerve femoralisblokkade without buprenorphine 0.3 mg?
8. Does buprenorphine 0.3 mg as an additive in nerve femoralisblokkade
immediately postoperatively improved sleep?
9. Does buprenorphine 0.3 mg as an additive in femoralisblokkade nerve in
orthopedic follow-up after 8 weeks show of a difference in knee function?
10. subcutaneous administration of 0.3 mg of buprenorphine give the same
results measured on the above variables, with respect to a dose of 0.3 mg of
buprenorphine in the femoral nerve?
Background summary
On 1 January 2007 had an estimated 240,000 men (95% confidence interval:
157,000 to 362,000) and 417,000 women (95% confidence interval: 283,000 to
597,000) osteoarthritis. This corresponds to 29.7 per 1,000 men and 50.4 per
1,000 women. All types (hip osteoarthritis, knee osteoarthritis and other
peripheral arthritis) are more common in women than in men. Knee Osteoarthritis
is most common voor.Het number of people with osteoarthritis increases with age
(5).
Within the Westfriesgasthuis Hoorn in 2011 a total of 273 total knee prostheses
implanted. For this operation, several types of anesthesia is used in the daily
praktijvoering, namely a general anesthesia (n = 15) or loco-regional
anesthesia in the form of a Vagus Femoralisblok in combination with a general
anesthesia (n = 151) or spinal anesthesia (n = 107) (4).
Study objective
The purpose of this study is to evaluate whether there are differences in
duration and intensity at a femoral nerve block with ropivacaine Klaris
standard 30ml 0.2% with and without addition of buprenorphine (Temgesic ®) 0.3
mg buprenorphine subcutaneously (0, 3mg).
Study design
In this research which an evaluation study were we are comparing the effect of
the intervention. (Buprenorphine as an additive in femoralisblok or
subcutaneously).
The type of study is a randomized clinical trial (RCT) with three arms. It is
performed as triple blind the patient to the color of the liquid can not
determine what he / she gets (ropivacaine or ropivacaine plus buprenorphine
local or ropivacaine plus buprenorphine subcutaneously or 1ml 0.9% NaCl
subcutaneously). Blinding of the patient is placed by the patient or 0.3 mg
buprenorphine subcutaneously or 1 ml NaCl 0.9%. The anesthesiologist that
performs nerve femoralisblokkade is blinded as he handed the injection given by
an employee. The Fluids are all watery and of equal volume. The final
independent data assessor is blinded, he has no understanding of what data is
from which patient.. The study has several time points postoperatively.
This design aims to see if there are differences in duration and intensity at a
femoral nerve block with ropivacaine Klaris standard 30ml 0.2% with and without
addition of buprenorphine (Temgesic ®) 0.3 mg.
There are three groups during this study were compared. (group R = ropivacaine
0.2% and 0.9% NaCl subcutaneously, group B = 0.2% ropivacaine + 0.3 mg
buprenorphine group and S = 0.2% ropivacaine plus buprenorphine 0.3 mg
subcutaneously).
Intervention
It is in this research to an evaluation study assessing the effect of the
intervention is viewed (buprenorphine as an additive in femoralisblokkade
Study burden and risks
In addition to the subcutaneous administration of buprenorphine or NaCl 0.9% in
the anesthetized leg and answering the questions QOL there is no risk compared
to the regular procedure
Maelsonstraat 3
1624 NP, Hoorn
NL
Maelsonstraat 3
1624 NP, Hoorn
NL
Listed location countries
Age
Inclusion criteria
18-80 years.
Elective total knee replacement,
Exclusion criteria
Fever, temperature higher than 37.5 degrees Celsius (orthopedic surgery don*t proceed)
Allergy to local anesthetics
Allergy to buprenorphine
pregnancy
Opiate use pre existent for surgery,
Infection of the skin at the area of the needle insertion opening in favor of Vagus femoralisblokkade.
Revision surgery of the knee.
General anesthesia instead of spinal anesthesia.
If patient is not under full anesthetic protocol policy for prosthetic hip and knee surgery.
EGFR <50 ml per minute.
Allergy to Non Steroid Anti Inflammatory Drugs (NSAIDS).
If pre-operative 10cm above the patella in the midline there is no left versus right difference in cold sensation than ithe block is tittled not sufficient and the patient will be removed from the study.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2012-20120605--NL |
| CCMO | NL40656.094.12 |