Hip Replacement Arthroplasty
Conditions
Brief summary
Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. The aim of this prospective, randomized, blinded study is to detect if stimulating catheters improve postoperative compared with conventional non-stimulating catheters.
Interventions
PROCEDUREContinuous lumbar plexus: stimulating catheter
Perinervous stimulating catheter (Stimulong, Pajunk, Germany) will be insert in lumbar plexus through tuohy needle (18G, 100mm length). 15ml mepivacaine 1% are injected before the complete resolution of the spinal anesthesia.
PROCEDURESpinal Anesthesia
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected.
PROCEDURELocal anesthetic infusion
Continuous infusion (Mini Rythmic Evolution, Micrel) of ropivacaine 0,2% at 3ml/h, bolus 3 ml, lockout time 15 min, 12 ml/h maximum dose through perinervous catheter until 3rd postoperative day
PROCEDUREIntravenous analgesia
Ketorolac 30mg 3 times a day
PROCEDUREOpioids rescue analgesia
Buprenorphine 0,2mg twice a day if VAS\>4
DRUGMepivacaine 1%
DRUGRopivacaine 0,2%
DRUGKetorolac 30mg
DRUGBuprenorphine 0,2mg
DEVICEStimulong, Pajunk, Germany.
PROCEDUREContinuous lumbar plexus: non-stimulating catheter
Sponsors
ASST Gaetano Pini-CTO
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients undergoing total hip arthroplasty
Exclusion criteria
* diabetes neurological disorders coagulation disorders rheumatoid arthritis chronic opioids therapy allergy to local anesthetic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local anesthetic consumption | 72h | Evaluation of local anesthesic consumption every 6h in first 72 postoperative hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Up and Go test | 4th postoperative day | up and go test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair |
| Opioids request | 72h postoperatively | Opioids consumption will be recorded throughout 72 postoperative hours |
| Quadriceps strength | preoperative and 24h, 48h, 72h postoperatively | evaluate bilateral muscle strength with an isometric force dynamometer to measure the force produced during a maximum voluntary isometric contraction in a lying position by the knee flex to 90°. |
| Visual Analog scale (VAS) score | 72h postoperatively | Evaluation of VAS static and VAS dynamic during first 72 postoperative hours |
| Needle redirections | During catheter position | During catheter positioning number of needle redirections necessary to found lumbar plexus are recorder. |
| Catheter insertion time | During catheter positioning | Time (minutes) needed for catheter placement |
| postoperative nausea and vomiting (PONV) | 72h postoperatively | Evaluation of nausea and vomit incidence in postoperative period with scale 0 from 4 |
Countries
Italy
Outcome results
None listed