Effect of intra- and postoperative strategy of pain management on functional outcome in patients subjected to knee arthroplasty.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24222

Enrollment

Registered

2010-02-09

Start date

2008-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

patients subjected to total knee arthroplasty

Interventions

In patients subjected to total knee arthroplasty post-operative pain therapy will be provided by patient controlled analgesia via femoral nerve blockade with or without single shot or continuous scia

Eligibility

Inclusion criteria

Inclusion criteria: 1. Informed consent; 2. American Society of Anesthesiologists (ASA) classification I to III; 3. Age older than 18 years.

Exclusion criteria

Exclusion criteria: 1. No informed consent; 2. ASA classification IV or V; 3. Infection near the insertion site; 4. Coagulation disorder, allergy to local anesthetics; 5. Pre-existing neurologic deficit of the operated leg; 6. Prior vascular surgery near the insertion site; 7. Inability to understand the patient controlled analgesia device; 8. Pregnancy or lactation period; 9. Known hepatic or renal insufficiency; 10. Age 18 years or younger.

Design outcomes

Primary

Measure	Time frame
Reaching of discharge criteria: 1. 90 degree flexion of the knee; 2. No infection; 3. 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; 3. Pain measured by VAS postoperatively on day 0, 1, 2 and 3 during rest and movement, respectively; 4. Postoperative nausea and vomiting; 5. Effect of removing catheters on functional aspects (loss of functional capacity after removing catheters); 6. Patient overall satisfaction (measured using the Oxford knee questionnaire, a score with good reliability, content validity and construct validity in patients subjected to TKA); 7. Patient satisfaction with regional blockade procedure (school marks); 8. Time necessary to place catheters; 9. Amperage of stimulation of motor response; 10. 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; 3. Pain measured by VAS postoperatively on day 0, 1, 2 and 3 during rest and movement, respectively; 4. Postoperative nausea and vomiting; 5. Effect of removing catheters on functional aspects (loss of functional capacity after removing catheters); 6. Patient overall satisfaction (measured using the Oxford knee questionnaire, a score with good reliability, content validity and construct validity in patients subjected to TKA); 7. Patient satisfaction with regional blockade procedure (school marks); 8. Time necessary to place catheters; 9. Amperage of stimulation of motor response; 10. Onset of motor and sensory block.

—

Contacts

Public ContactB. Preckel

Department of Anesthesiology, Academic Medical Center University of Amsterdam, Meibergdreef 9 Postbus 22660 H1Z-120

b.preckel@amc.uva.nl+31 20 5662162,

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)