Analgesic efficacy a nerve blockade in the mid thigh for outpatient knee anterior cruciate ligament surgery

• Conditions: Mid thigh saphenous nerve block with levobupivacain, as compared to femoral nerve block, in patients undergoing anterior cruciate ligament surgery; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-003684-54-NL
• Lead Sponsor: Academic Medical Center Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-23
• Last Update Posted: 31 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Readiness to discharge in hours and according to Post-Anesthetic Discharge Scoring System (PADSS);Secondary Objective: - VAS score <br>- Overall Benefit of Analgesia Score (OBAS)<br>- Lysholm score<br>- SF-12<br>- Sensory blockade extent <br>- Time to rescue analgesic (morphine postoperatively)<br>- Total analgesic consumption (telephone interview)<br>- Time to mobilization (telephone interview)<br>- Knee function will be done by the Knee Society 6 weeks after surgery<br>- 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 Outcome Measures

Name	Time	Method
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). <br>-Overall Benefit of Analgesia Score (OBAS), determined on the day of surgery, and the first postoperative day.[23]<br>D 0:<br>- KOOS-, IKDC questionnaire, SF12- Sensory blockade extent one hour postoperatively (focusing on concomitant blockade of the saphenous or femoral nerve). <br>- Time to rescue analgesic (morphine postoperatively)<br>- Total analgesic consumption (telephone interview)<br>- Time to mobilization (telephone interview)<br>D1- OBAS (telephone interview)<br>- Knee function will be done by the Knee Society 6 weeks after surgery<br>- Incidence of falls or near falls 6 weeks<br>- WOMAC, SF-12;Secondary end point(s): The secundary endpoints are expected to be at least as effective compared to the control group