Ropivacaine Versus Bupivacaine as Preemptive Analgesia in Surgical Site in Ankle Fracture Patients
Condition: Ankle Fractures; Pain, Postoperative; Local Infiltration
MeSH terms: Pain, Postoperative; Fractures, Bone; Ankle Fractures
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    


Intervention name(s): Ropivacaine; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): It will be used as a analgesic dose in surgical site before surgery.; It will be used as a analgesic dose in surgical site before surgery.
Other intervention name(s): Naropin; Bupivacaine hydrochloride
Intervention MeSH terms: Bupivacaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention