Determining the outcome of reversed and antegrade LIA in THA with ASI by analysing postoperative pain with the 100 mm Visual Analogue Scale (NRS), length of hospital stay, the amount of postoperative consumption of opioid pain medication as well as…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Pain score (NRS) at day 1 at multiple moments: 1, 4 and 8 hours after
operation in rest, and while and direct after mobilization starting at 4-6
hours after operation. At day 2 until the day of discharge at two moments. Also
during and immediately after mobilization.
- Preoperative pain will be scored during the preoperative
screening.
- POVN is asked at the moments the VAS is scored.
- Cumulative consumption of opioid medication and pain medication.
- Length of Hospital Stay by amount of nights and number of hours between
operation and discharge.
Secondary outcome
not applicable
Background summary
Local infiltration analgesia (LIA) is widely applied as part of a multimodal
pain management strategy in total hip arthroplasty (THA). The optimal way of
infiltration and dose of perioperative consummated pain medication are not
known.
In Reinier de Graaf Groep (RdGG) the Anterior Supine Intermuscular technique
(ASI) is being used for THA procedures. This technique will allow the patient
to mobilize much earlier postoperatively compared to other techniques. However,
it has been hypothesized that it will result in more pain directly
postoperative. Therefore, this study will investigate the effect of LIA in
combination with the ASI technique.
Study objective
Determining the outcome of reversed and antegrade LIA in THA with ASI by
analysing postoperative pain with the 100 mm Visual Analogue Scale (NRS),
length of hospital stay, the amount of postoperative consumption of opioid pain
medication as well as the consumption of other pain medication. The amount of
nausea and vomiting will also be determined. Also, preoperative pain will be
scored as well as the amount of medication used during surgery.
Study design
This study is a randomised, placebo controlled blind (for the patient) trial
comparing the outcome in one group of interest, the total hip arthroplasty
group, using three local infiltration analgesia (LIA) techniques.
Patients with coxarthrosis, who qualify for a THA by ASI, will get local
infiltration analgesia during operation. They will be randomised into 3 groups.
Group 1 will be given LIA by antegrade infiltration. Group 2 will be given LIA
by reversed infiltration. Group 3 will be given placebo LIA by antegrade
infiltration.
Intervention
Local infiltration analgesia (LIA) during THA procedures.
Study burden and risks
Patients will receive their planned THA. There will be three more clinical
control moments to measure the NRS in comparison to normal THA-patients: one
hour after operation, during and immediately after first mobilisation. Patients
in the placebo group can have more pain when compared to the patients in the
other two groups. All patients will receive rescue medication when the standard
pain medication is insufficient.
There will be no extra control moments after discharge when compared to normal
THA-patients.
Reinier de Graafweg 3-11
Delft 2625AD
NL
Reinier de Graafweg 3-11
Delft 2625AD
NL
Listed location countries
Age
Inclusion criteria
The hospital criteria for patients diagnosted for a total hip arthroplasty with osteoarthritis will be applied
* Patients aged 18 years and older.
* Patients willing to participate.
* ASA I and II.
Exclusion criteria
* Patients unwilling to participate.
* Mentally retarded.
* Neurological conditions potentially influence pain perception.
* Psychiatric conditions potentially influence pain perception.
* ASA III, IV and V.
* Cardiovascular impairment inthe present and the past.
* Abuse of alcohol or drugs.
* Known allergy for any element of the medication that is given (ropivacain, epinephrin).
* Medical contra indication for spinal anaesthesia.
* BMI > 40.
* Rheumatoid arthritis.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| EudraCT | EUCTR2012-000989-37-NL |
| CCMO | NL39970.098.12 |