Efficacy of Peripheral Nerve Blocks in Rizarthrosis Ambulatory Surgery
The purpose of this study is to determinate if peripherical block of radial and median nerves at the elbow guided by ultrasound, and using local anesthetic with a long-term and low concentration, are effective in the treatment of postoperative severe pain due to a selective sensory block at the surgical site.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Added Blocking Effectiveness of the Radial and Median Nerves With Levobupivacaine in Postoperative Pain Control in Rizarthrosis Ambulatory Surgery|
- Effectiveness of peripherical nerve blockade [ Time Frame: 2 years ] [ Designated as safety issue: No ]The primary endpoint will assess pain measured by visual analogue scale numerical pain (VAS). Determine the maximum VAS and the VAS at 24 and 48 hours postoperatively. The analysis of this variable at the end of the study will confirm or not the effectiveness of proposed therapeutic strategy.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
In the other group (R), we practice the peripherical nerves blockade guided by ultrasound and neurostimulator.
In group R, we practice a peripheral blockade on radial and median nerves using a local anesthetic and long-term low concentration: 0.125% levobupivacaine, 5 ml per nerve, a total dose of 6.25 mg. These blocks are guided by ultrasound and neurostimulator.
No Intervention: No intervention
In one group (H) any intervention is practiced.
This study is a prospective randomized clinical trial, including patients undergoing outpatient rizarthrosis surgery. The 50 patients will be randomized into 2 groups:
A. Group H (n = 25): Usual procedure is performed (axillary block under ultrasound guidance with the aid of a neurostimulator) using a local anesthetic with a short-term action (2-3 hours): mepivacaine 1%.
B. Group R (n = 25): Usual procedure + additional intervention: Axillary block (mepivacaine 1%) and peripherical radial and median nerves block at the elbow (levobupivacaine 0.125%, 5ml/nerve),also under ultrasound guidance with the help of a neurostimulator.
Postoperative analgesia is the same for the 2 groups of patients: fixed pattern of dexketoprofen and rescue pattern of Tramadol.
The primary endpoint is analyse postoperative pain at 24 and 48 hours of surgery in the 2 study groups, as measured by visual analog scale pain numeric (VAS24 -48) and the maximum VAS.
Data collection will be done by a nurse of the outpatient surgery area by a phone call at 24 and 48 hours postsurgery.
Other variables that we collected are:
- VAS at the time of the call.
- Maximum VAS.
- Time of onset of pain after hospital discharge.
- Need for rescue analgesia, and total dose used.
- Presence of nausea or vomiting, and medication used to control them.
- Presence of motor block and time reversal.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597479
|Contact: Mireia R Rodríguez, anesthesiologist||+34 firstname.lastname@example.org|
|Contact: Rolf Hoffman, anaesthesiologist||+34 5537541 ext H||RHoffman@santpau.cat|
|Hospital de la Santa Creu i Sant Pau||Recruiting|
|Barcelona, Spain, 08025|
|Contact: Mireia Rodriguez, MD + 34 93 553 75 41 email@example.com|
|Contact: Rolf H Hoffman, MD + 34 93 553 75 41 firstname.lastname@example.org|
|Principal Investigator: Mireia R Rodríguez, anesthesiologist|
|Principal Investigator:||Mireia Rodriguez, MD||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|