Mid thigh saphenous nerve block with levobupivacain, as compared to femoral nerve block, in patients undergoing anterior cruciate ligament surgery
Conditions
Interventions
Trade Name: Chirocaine
Product Name: Chirocaine
Product Code: SUB02904MIG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LEVOBUPIVACAINE
CAS Number: 27262-47-1
Other descriptive name
Sponsors
Academic Medical Center Amsterdam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed consent, age 18-65 years, ASA status I - III, rupture of the anterior cruciate ligament. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Inability to perform written informed consent, contraindication for regional anesthesia, contraindication for general anesthesia, allergy against local anesthetics, BMI > 35, pre-existing diagnosed neuropathy of the operated leg, ingestion of strong opioids, pregnancy or breastfeeding status. History of significant cardiovascular disease (MI, CVA, peripheral vascular disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Readiness to discharge in hours and according to Post-Anesthetic Discharge Scoring System (PADSS);Secondary Objective: - VAS score - Overall Benefit of Analgesia Score (OBAS) - Lysholm score - SF-12 - Sensory blockade extent - Time to rescue analgesic (morphine postoperatively) - Total analgesic consumption (telephone interview) - Time to mobilization (telephone interview) - Knee function will be done by the Knee Society 6 weeks after surgery - Incidence of falls or near falls;Primary end point(s): Shortening of readiness to discharge in hours (20%) ;Timepoint(s) of evaluation of this end point: Post-operatively on day of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - VAS score hourly until discharge, and on the morning and evening of the first postoperative day (telephone interview) together with OBAS on first postoperative day). -Overall Benefit of Analgesia Score (OBAS), determined on the day of surgery, and the first postoperative day.[23] D 0: - KOOS-, IKDC questionnaire, SF12- Sensory blockade extent one hour postoperatively (focusing on concomitant blockade of the saphenous or femoral nerve). - Time to rescue analgesic (morphine postoperatively) - Total analgesic consumption (telephone interview) - Time to mobilization (telephone interview) D1- OBAS (telephone interview) - Knee function will be done by the Knee Society 6 weeks after surgery - Incidence of falls or near falls 6 weeks - WOMAC, SF-12;Secondary end point(s): The secundary endpoints are expected to be at least as effective compared to the control group | — |
Countries
Netherlands
Contacts
Public ContactWerner ten Hoope
Academic Medical Center
Outcome results
None listed