The primary goal of this study is to determine if there are any benefits in addition of pregabalin and s-ketamine to local knee infiltration with ropivacaine/adrenaline/kenacort®, regarding the analgesia and the early mobilization in the study group…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PRIMARY PARAMETER IS:
Range of motion / Knee flexion angle
The knee flexion angle is measured from the first postoperative day (Day 1),
until the day of discharge (DD), by a physical therapist as (flexion_1,flexion
_2, flexion_3, flexion_4, flexion_5, flexion_DD).
Secondary outcome
SECONDARY PARAMETERS ARE:
Pain
The standard Numeric Rating Scale (NRS) is used to measure pain. The patient
can grade the intensity of knee related pain on a scale of 0-10, where 0 means
no pain and 10 is the worst imaginable pain. The NRS is recorded on the day 0
in the recovery: NRS0-R, and in the ward: NRS0-W; on the day 1 (NRS1 four times
a day) ; on the day 2 (NRS2 four times a day) by a nurse on the ward. From a
day one to day five, a physical therapist will note the dynamic pain scores
(NRS-d), during the exercises (NRS1-d to NRS5-d).
Piritramide consumption
All patients are instructed to use PCA-piritramide, if they have knee pain.
They may receive a 1 mg piritramide on demand, during the first 48 hours.
Piritramide is given as a rescue medication and the total consumption per day
will be noted.
S-Ketamine / pregabalin possible side effects
The state of sedation will be assessed as a 4-point score:
0 = no sedation, 1 = mild sedation, 2 = moderate sedation, 3 = severe sedation
during the first 24 hours.
Postoperative nausea and vomiting
PONV will be registered as: absent, mild or heavy.
Length of hospital stay
The length of hospital stay is noted as the number of days between the day of
surgery and discharge from the hospital ( or readiness to discharge).
Patients` satisfaction
The patient*s satisfaction with the postoperative analgesia is recorded before
discharge. This is done on a 4 point scale; 1 = poor, 2 = fair, 3 = good, or 4
= excellent.
An independent physician will measure the knee function six weeks, three
months and one year after surgergery. In addition, pain at rest and movement
will be scored, and the satisfaction with the TKA assessed, each time.
The Knee Society score (KSS) and Western Ontario and McMaster Universities
Osteoarthritis Index (WOMAC) questionnaires are used . The KSS is divided in a
part with knee related questions (KSS_knee) and a functional scale
(KSS_function). The WOMAC is divided in a pain scale (WOMAC_pain), stiffness
scale (WOMAC_stiffness) and a functional scale (WOMAC_function). All subscales
of the KSS and WOMAC have a range of 0-100.
Background summary
ABSTRACT
Background: TKA often produces severe postoperative pain. Reduction of pain is
an important factor in the early rehabilitation of these patients. There is
some evidence, that the addition of pregabalin and s-ketamine may not only
reduce the acute postoperative pain, but also the incidence of chronic
postoperative pain in these patients. Some studies also show that the
intra-articular injection of corticosteroids may be beneficial and even shorten
the hospital stay. Lately, there are randomized, controlled studies showing
that intra and peri-articular infiltration with local anesthetics, after TKA,
due to its simplicity and low complication risk, may be a good alternative to
different loco-regional techniques such as femoral block and epidural
analgesia.
Methods: This study is a prospective, randomized, double blind, controlled
evaluation of two methods of analgesia, after TKA. For the process of
randomization computer generated random numbers will be used.
The patients will be operated under spinal anesthesia. The intra- and
peri-articular local anaesthetic infiltration with
ropivacaine/adrenaline/kenacort®, will be given ( during the operation) to the
study group, with the addition of pregabalin and s-ketamine in the first
postoperative days. In the control group, the same local anesthetic knee
infiltration will be performed during the surgery. Only, instead of pregabalin
per os, the control group will get placebo and instead of s-ketamine, the
normal saline infusion.The studie medication will be prepared by the Department
of Clinical Pharmacology and will be blinded for the patient and the resarch
team.
Our research question is:
Can the addition of s-ketamine and pregabalin reduce the acute pain and enhance
the range of motion in the early postoperative period after TKA?
The secondary goal is to determine if the edition of s-ketamine and pregabalin
can reduce the incidence of chronic pain after TKA and improve the long term
functional results?
Study objective
The primary goal of this study is to determine if there are any benefits in
addition of pregabalin and s-ketamine to local knee infiltration with
ropivacaine/adrenaline/kenacort®, regarding the analgesia and the early
mobilization in the study group, compared to the control group (getting
placebo).
Our research question is:
Can the addition of s-ketamine and pregabalin reduce the acute pain and enhance
the range of motion in the early postoperative period after TKA?
The secondary goal is to determine if the edition of s-ketamine and pregabalin
can reduce the incidence of chronic pain after TKA and improve the long term
functional results?
Study design
This study is a prospective, randomized, double blind, controlled evaluation of
the value of the additional analgesics after TKA. The surgery will be done
under spinal anesthesia.During surgery, intra- and peri-articular local
anaesthetic infiltration with ropivacaine/adrenalin/kenacort®, will be given to
the study group, with the addition of pregabalin and s-ketamine in the first
postoperative days. In the control group, the same knee infiltration will be
performed, only instead of pregabalin per os, the control group will get
placebo, and instead of s-ketamine, the normal saline infusion.
The studie medication will be prepared by the Department of Clinical
Pharmacology and will be blinded for the patient and the resarch team.
For the process of randomization computer generated random numbers will be used.
The head orthopedic nurse will open the envelope before the operation (deciding
to which group the patient belongs) and bring the study medication to the
operation theatre. This person will be responsible for the correct process of
randomization and registration of the given medication.
Based on power analysis, 60 patients scheduled for primary TKA at the Radboud
University Nijmegen Medical Centre, The Netherlands, will be randomly allocated
to either study or control group, during the period of two years.
Intervention
In the study group,150 mg of pregabalin will be given per os with
premedication. It will be continued, twice a day during the first three
postoperative days. The dose will be reduced to 75 mg two times a day ABOVE THE
AGE OF 65 AND ASA III. The control group will get placebo.
At the beginning of a surgery, study group will also receive an intravenous
bolus of 5-10 mg S-ketamine.This will be followed by a 24 hours continuous
infusion, at the rate of 2,5-10 mg/hour ( dose reduction for ASA III AND ABOVE
THE AGE OF 65 YEARS. ).The control group will get normal saline infusion,
instead.
Study burden and risks
There is no extra burden for these patients. Only the registration of the data
of the knee related pain and the achieved range of motin will be more
frequently recorded. All adverse events or complications will be registered.
The research will not cause any delay or change in the operative procedure.
The additional antihyperalgesic medication (pregabalin and s-ketamine) may
cause drowsiness or dissiness. The patient will receive both of these drugs on
the day of operation, will be closely observed and will stay in bed.
At the beginning of the 1st postoprative day s-ketamine will be stopped (7 am).
Pregabalin will be continued per os during the first three postoperative days (
during the hospitalization, only).
The dose of both drugs will be adjusted according to physical status and the
age of the individual patient.The dose will be reduced in elderly and sick
patients.
Expected benefits are: improvement of early and long terme functional results
after TKA.
Geert Grooteplein10
6500HB Nijmegen
NL
Geert Grooteplein10
6500HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
patients scheduled for total knee arthroplasty
Exclusion criteria
patient refusal; preexisting neurological or psychiatric illnesses; chronic pain syndrome; alcohol or drug abuse; SUSPECTED POSSIBILITY OF POSTOPERATIVE DELIRIUM , difficulties in communication or expected inability to understand patient-controlled analgesia; rheumatoid arthritis, revision knee surgery or participation in another 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 | EUCTR2011-002019-27-NL |
| CCMO | NL35558.091.11 |
| Other | NRT 9102 |