Pain, Postoperative Clinical Trial
Official title:
Ropivacaine Versus Bupivacaine as Preemptive Analgesia in Surgical Site in Ankle Fracture Patients
Title: Ropivacaine versus Bupivacaine as Preventive Analgesia in Surgical Incision Site In
Patients With Ankle Fracture Background: Ankle fractures are about 10% of the fractures
associate to sports and with an incidence of 0.11 of 1000 adult patients. Weber
classification system divides ankle fractures in three types according to the anatomy of
lateral malleolus. B fractures starts at tibia pilon. Stable fractures are easily treated in
conservative way. (12) Unstable fractures are treated surgically with anatomic reduction and
internal fixation. However, it's been reported that even with successful reduction surgically
great results are not always achieved. Local wound infiltration blocks the pain in its
origin, surgical site by itself, without alter motor function. Practically without presenting
adverse events with this method. it´s accurate for ambulatory surgery.
Main Objetive: To compare preventive analgesia with local anesthetic in surgical site with
ropivacaine or bupivacaine in ankle fracture patients treated surgically with open reduction
and internal fixation.
Method: Two groups with ankle fractures which will be informed and the patients will sign
informed consent, after that the patients will be assign to a group (Ropivacaine or
bupivacaine). The patient will be prepared for surgical treatment according to his doctor. It
will be applied traditional anesthesia. It will be applied before beginning surgery in
bupivacaine group 25 mg and in ropivacaine group 37.5 mg at least 10 minutes before starting
surgery. After that the patient will have the traditional dose of analgesic treatment.The
group will evaluate the pain with VAS 0-10 at 4,8,12 and 24 hours after surgery. The group
will register data and will make statistic analysis. It will be elaborated the conclusion an
elaboration of a report.
Resources: The group counts with human resources of the group of investigators. The hospital
has in emergency department almost three patients with ankle fractures each day which require
surgical treatment. The hospital has x ray service to valuate the ankle fracture and with
computer system to analyze it. The hospital has the software for statistical analysis.
Experience: The group is formed with orthopedic surgeons with more than 5 years in treatment
of ankle fractures. Investigators have the support of pain medicine group in hospital and
with anesthesia coordinators. Investigators have a group of orthopedic residents which will
be encharged of ilfiltration wound site.
Time: September 2016 to February 2017.
n/a
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