DOES THE ADDITION OF PREGABALIN AND S-KETAMINE TO LOCAL KNEE INFILTRATION, IMPROVE THE POSTOPERATIVE KNEE FUNCTION OUTCOME AFTER TOTAL KNEE ARTHROPLASTY?

DOES THE ADDITION OF PREGABALIN AND S-KETAMINE TO LOCAL KNEE INFILTRATION, IMPROVE THE POSTOPERATIVE KNEE FUNCTION OUTCOME AFTER TOTAL KNEE ARTHROPLASTY? - THE EFFECT OF PREGABALIN AND S-KETAMINE AFTER TOTAL KNEE ARTHROPLASTY

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36143

Enrollment

Registered

2011-07-21

Start date

2011-11-11

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

posoperative analgesia after total knee arthroplasty

Interventions

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 ti

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients scheduled for total knee arthroplasty

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 s	—

Measure

Time frame

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 s

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)