Effect of Pregabaline and S-Ketamine on knee function after total knee arthroplasty.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR2761
• Date of registration: 11/02/2011
• Primary sponsor: University Medical Center Nijmegen
• Public title: Effect of Pregabaline and S-Ketamine on knee function after total knee arthroplasty.
• Scientific title: Does the addition of Pregabaline and S-Ketamine to local knee infiltration improve the postoperative knee function after total knee arthroplasty? - THE EFFECT OF PREGABALIN AND S-KETAMINE ON THE KNEE FUNCTION OUTCOME, AFTER TOTAL KNEE ARTHROPLASTY
• Date of first enrolment: 1/4/2011
• Target sample size: 60
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2761
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: Single arm

Countries of recruitment

The Netherlands

Contacts

• Name: Oliver H.G. Wilder-Smith

• Name: Lajla Kadic

Key inclusion & exclusion criteria

Inclusion criteria: Patients aged 18 to 80 years, listed for total knee arthroplasty are eligible for this study.

Exclusion criteria: 1. Patient refusal;

2. Preexisting neurological or psychiatric illnesses;

3. Chronic pain syndrome;

4. Alcohol or drug abuse;

5. Difficulties in communication or expected inability to understand patient-controlled analgesia;

6. Rheumatoid arthritis;

7. Revision knee surgery;

8. Participation in another study.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Total knee arthroplasty, S(+)-ketamine, Local knee infiltration

Intervention(s)

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 in elderly patients. The control group will get placebo.



At the beginning of the surgery, the 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 5-10 mg/hour (dose reduction for elderly).The control group will get normal saline infusion instead.

Primary Outcome(s)

1. 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 (flexion_1,flexion _2, flexion_3, flexion_4, flexion_5, flexion_DD);

2. 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 day one to day five, a physical therapist will note the dynamic pain scores (NRS-d), during the exercises (NRS1-d to NRS5-d);

3. 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;

4. S-Ketamine / pregabalin possible side effects;

5. 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;

6. Postoperative nausea and vomiting: PONV will be registered as: absent, mild or heavy;

7. 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);

8. 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.

Secondary Outcome(s)

An independent physician measures the knee function six weeks, three months and one year after surgery. In addition, pain at rest and movement wil 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.

Secondary ID(s)

35558

Source(s) of Monetary Support

University Medical Center Nijmegen