To quantify the amount of local anaesthetic in shed blood in the Bellovac ABT system and in the blood circulation of the patient. The primary objective is to detect the course of ropivacaine levels in the shed blood collected with the Bellovac ABT…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ropivacaine will be quantified in patient serum (0, 1, 3, 6, 7 and 18-24 h
after surgery) and in the shed blood collected with the Bellovac ABT system at
the same time points postoperative.
Secondary outcome
- VAS pain scores measured per protocol
- Opioid consumption (amount of morfine used with PCA pump) 24, 48 and 72hrs
- Several important time points will be documented; start operation, injection
of single shot, tourniquet release, leaving recovery and blood samples
Background summary
Evidence suggests that local analgesia after total knee replacement (TKR)
provides better knee function in the postoperative period with less
post-operative complications like nausea and vomiting as compared to
conventional ways of pain treatment (i.e.opioids). The Bellovac ABT system; a
technique to collect, filter and reinfuse shed blood, is also often used in
TKR. Bellovac ABT is used as an alternative to allogeneic blood transfusion. A
combination of both techniques however, is not common yet. Before routinely
combining local analgesia with the Bellovac ABT technique we have to know the
amount of ropivacaine in the shed blood collected with the Bellovac ABT system.
As complement on the already collected data from earlier research is the course
of the ropivacaine levels in the collected shed blood.
Study objective
To quantify the amount of local anaesthetic in shed blood in the Bellovac ABT
system and in the blood circulation of the patient. The primary objective is to
detect the course of ropivacaine levels in the shed blood collected with the
Bellovac ABT system and in patients plasma.
Study design
Patients will be asked to participate in the trial. After inclusion, patients
will be operated and during surgery a field block is given using two single
shots with ropivacaine and adrenaline. After closure of the subcutis and before
the cutis will be closed a last block will be injected subcutaneous without
adrenaline. After surgery, patients receive a Bellovac ABT (wound) drain in the
knee joint. The blood collected with the Bellovac ABT system and blood samples
from the patient will be collected at 0, 1, 3, 6, 7 and 18-24 (first
postoperative morning) hours after operation when the wound drain will be
removed.
Study burden and risks
Extra blood samples will be collected to quantify the ropivacaine in patient
serum. Collection of shed blood in the Bellovac ABT does not imply extra risks
of burden to the patient.
Lijnbaan 32
2501 CK Den Haag
NL
Lijnbaan 32
2501 CK Den Haag
NL
Listed location countries
Age
Inclusion criteria
- primary TKP
- Haemoglobin level above 7.5 mmol/L
- both arms can be used for blood collection
Exclusion criteria
- allergic for used medication or other local anaesthetics
- major operation within 12 weeks before TKP surgery
- high risk patients for insultus epilepticus
- dutch language not mastered
Design
Recruitment
metc-ldd@lumc.nl
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 | NL33364.098.10 |