The goal of the pilot study is to compare LIA with or without adrenaline infiltration by means of post operative pain (VAS) scores, PONV, early mobilisation and early discharge criteria.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
VAS-painscore, post operative pain relief
- Direct after the operation
- Before and after the first mobilisation
- Pain measure 3 times a day on standard time 3 a day on fixed intervals until
discharge
Secondary outcome
- Amount of post operative analgesia use direct post operative till day of
discharge
- Time to fisrt mobilisation
- Length of hospital stay
- Adverse events/complications: Intra-operative, post-operative during pilot
study
Background summary
Postoperative pain is one of the most common complaints after total knee
arthroplasty. Excessive postoperative pain, nausea and/or vomiting (PONV)
ensure to delay (early) mobilization, early recovery and are the most common
reasons for unnecessary prolonged hospital stay. Early mobilisation of these
patients frequently depends on recovery from anesthesia. Recently, a local
infiltration analgesia (LIA) technique was developed by Kerr and Kohan( Sydney,
Australia). With this LIA-technique, a long-acting local anesthetic
(ropivacaine) is infiltrated intraoperatively. LIA is common described in
literature in total knee arthroplasty with favourable results. It decreases
post operative pain and PONV and allows patients to mobilise within <6 hours
post operative. These patients are able to be discharged 2 days earlier
compared to patients not infiltrated with LIA. Local infiltration analgesia in
knee joint replacement surgery is associated with reduced post operative pain
relief, early mobilisation and hospital discharge. Combination of ropivacaine
with adrenaline is common used in literature. With the following pilot study we
want to determine whether adrenaline affects the postoperative pain relief
after total knee arthroplasty.
Study objective
The goal of the pilot study is to compare LIA with or without adrenaline
infiltration by means of post operative pain (VAS) scores, PONV, early
mobilisation and early discharge criteria.
Study design
Clinical, Randomised, double blind, pilot study
Intervention
Local Infiltration analgesia with ropivacaine with or without adrenaline.
Study burden and risks
NA
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Listed location countries
Age
Inclusion criteria
• Painful and disabled knee joint resulting from osteoarthritis
• High need to obtain pain relief and improve function
• Able and willing to follow instructions
• Informed consent
Exclusion criteria
• Active infection in knee
• General infection
• Distant foci of infections which may spread to the implant site
• Failure of previous joint replacement
• Pregnancy
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 | EUCTR2013-005401-31-NL |
| CCMO | NL45980.096.14 |