Postoperative Pain Clinical Trial
— API-KNEEOfficial title:
Catheter-based Peripheral Regional Anesthesia After Total Knee Arthroplasty: Comparison of Low Dose, Automated Periodic Infusions With Conventional High Dose, Continuous Infusion and Patient-initiated Infusions Only
Verified date | September 2019 |
Source | Nordsjaellands Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
BACKGROUND
Total knee arthroplasty can be severely painful, and peripheral regional anesthesia is highly
recommended as part of the perioperative pain treatment. Whether catheter-based techniques
are better than single injection techniques are debatable. Furthermore, in catheter-based
techniques, whether a low-dose automated, periodic infusion can produce similar analgesic
effectiveness compared to a conventional, high dose, continuous infusion has never been
explored.
AIM Comparison of the analgesic effectiveness of a low-dose automated, periodic infusion, a
conventional continuous infusion and patient-controlled boluses only in catheter-based
adductor canal blocks for patients undergoing total knee arthrplasty.
Status | Completed |
Enrollment | 111 |
Est. completion date | April 1, 2019 |
Est. primary completion date | February 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: 1. Age = 18 years 2. American Society of Anesthesiologists Classification I-III 3. Normal cognitive function in order to sign written, informed consent and to understand trial protocol 4. Agreement to the trial protocol, including the randomized manner Exclusion Criteria: 1. Allergy to LA 2. Infection in or near insertion site of the peripheral nerve catheter 3. Anatomical abnormalities preventing successful peripheral catheter insertion 4. Habitual use of opioids 5. Pregnancy or breastfeeding (disproved by a negative pregnancy test before trial inclusion) |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Anesthesiology, Nordsjællands Hospital Hillerød | Hillerød |
Lead Sponsor | Collaborator |
---|---|
Nordsjaellands Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Opioid related side effects | Patient reported symptoms: dizziness, nausea, itching, constipation | 1-72 hours | |
Other | Pain at bolus request | Pain (VAS, 0-100 milimetres) at the time of patient-initiated bolus | 1-72 hours | |
Other | Motor nerve block | Degree of motor nerve block, defined by paresis or paralysis in the knee flexion | 1-72 hours | |
Other | Sensory nerve block | Insensitivity towards cold in the lateral aspects of the lower leg and beneath the foot. This will be recorded by the patient using a cold glass vial stored in a refrigator until its use | 1-72 hours | |
Primary | Postoperative pain, 1-72 hours postoperatively | Postoperative pain using the visual analogue pain scale (VAS, 0-100 milimetres). Measurements will be patient-reported. | 1-72 hours | |
Secondary | Opioid consumption, 1-72 hours postoperatively | Tablets consumed during the period of investigation | 1-72 hours | |
Secondary | Volume of patient-initiated boluses, 1-72 hours postoperatively | Volume of ropivacaine 0.2 % (mL) used for patient-initiated boluses, 1-72 hours postoperatively | 1-72 hours |
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