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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Ankle Fractures; Local Infiltration
• Intervention / Treatment: Drug: Bupivacaine; Drug: Ropivacaine

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Ciudad de Mexico, Mexico, 07020
    • UMAE Dr. Victorio de La Fuente Narvaez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient with afiliation to IMSS
• Patient with ankle fracture that requires surgical treatment with open reduction and internal fixation
• Patient that accept to participate in the study whit a sign of document.

Exclusion Criteria:

• Politrauma patients (Patients with another fracture)
• Patients who dont accept to participate in the study
• Neuropathy in inferior limps that limits pain perception
• Open ankle fractures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupivacaine; It will be used bupivacaine in surgical site prior surgery (25 mg). At least 10 minutes before skin incision.	Drug: Bupivacaine; It will be used as a analgesic dose in surgical site before surgery.; Other Names: Bupivacaine hydrochloride
Experimental: Ropivacaine; It will be used ropivacaine in surgical site prior surgery (37.5 mg). At least 10 minutes before skin incision.	Drug: Ropivacaine; It will be used as a analgesic dose in surgical site before surgery.; Other Names: Naropin
No Intervention: Control; No application of anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	The Pain will be measured with this scale from 0 (No pain) -10 (Worst pain possible) according to the investigator at 24 hours after surgery.	Change in Visual Analogue Scale at 24 hours

Collaborators and Investigators

• Sponsor: Instituto Mexicano del Seguro Social
• Investigators: Study Chair: Juan Jonathan De La Cruz Pacheco, IMSS

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): December 31, 2018
• Last Update Submitted That Met QC Criteria: July 1, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Pain, Postoperative; Fractures, Bone; Ankle Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: R-2016-3401-55