Effect of intra- and postoperative strategy of pain management on functional outcome in patients subjected to total knee arthroplasty (TKA)

Effect of intra- and postoperative strategy of pain management on functional outcome in patients subjected to total knee arthroplasty (TKA) - Regional anesthesia in total knee arthroplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32063

Enrollment

Registered

2008-01-14

Start date

2008-02-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

total knee arthroplasty

Interventions

Group A: ultrasound guided introduction of a stimulated femoral nerve catheter Intraoperative pain therapy: levo-bupivacaine 0.375% 20 ml followed by continuous infusion of levo-bupivacaine 0.125% 1

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Informed consent, American Society of Anesthesiologists (ASA) classification I to III, age older than 18 years

Exclusion criteria

Exclusion criteria: no informed consent, ASA classification IV or V, infection near the insertion side, coagulation disorder, allergy to local anesthetics, pre-existing neurologic dysfunction, prior vascular surgery near the insertion side, inability to understand the patient controlled analgesia device, pregnancy or lactation period, known hepatic or renal insufficiency, age

Design outcomes

Primary

Measure	Time frame
Reaching of discharge criteria (90 degree flexion of the knee, no infection, pain on the visual analogue scale (VAS) lower than 4 (scale 0-10)	—

Secondary

Measure	Time frame
1. functional results at discharge and after 6 weeks and one year after the operation, 2. Analgesic consumption: use of morphine and tramadol, pain measured by VAS postoperatively on day 0, 1, 2 and 3 during rest and movement, respectively, 3. Postoperative nausea and vomiting (PONV, 0: absence, 1: mild, 2: severe), 4. Effect of removing catheters on functional aspects (loss of functional capacity after removing catheters), 5. Patient overall satisfaction (measured using the Oxford knee questionnaire, a score with good reliability, content validity and construct validity in patients subjected to TKA15;16)Patient satisfaction with regional blockade procedure (school marks), 6. Time necessary to place catheters, 7. Amperage of stimulation of motor response, 8. Onset of motor and sensory block	—

Measure

Time frame

1. functional results at discharge and after 6 weeks and one year after the operation, 2. Analgesic consumption: use of morphine and tramadol, pain measured by VAS postoperatively on day 0, 1, 2 and 3 during rest and movement, respectively, 3. Postoperative nausea and vomiting (PONV, 0: absence, 1: mild, 2: severe), 4. Effect of removing catheters on functional aspects (loss of functional capacity after removing catheters), 5. Patient overall satisfaction (measured using the Oxford knee questionnaire, a score with good reliability, content validity and construct validity in patients subjected to TKA15;16)Patient satisfaction with regional blockade procedure (school marks), 6. Time necessary to place catheters, 7. Amperage of stimulation of motor response, 8. Onset of motor and sensory block

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)