Ambulatory Rizarthrosis Surgery Clinical Trial
Official title:
Added Blocking Effectiveness of the Radial and Median Nerves With Levobupivacaine in Postoperative Pain Control 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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment