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Ropivacaine Versus Bupivacaine as Preemptive Analgesia in Surgical Site in Ankle Fracture Patients

Primary Purpose

Ankle Fractures, Pain, Postoperative, Local Infiltration

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Ropivacaine
Bupivacaine
Sponsored by
Instituto Mexicano del Seguro Social
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ankle Fractures

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UMAE Dr. Victorio de La Fuente Narvaez

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Bupivacaine

Ropivacaine

Control

Arm Description

It will be used bupivacaine in surgical site prior surgery (25 mg). At least 10 minutes before skin incision.

It will be used ropivacaine in surgical site prior surgery (37.5 mg). At least 10 minutes before skin incision.

No application of anesthetic

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 25, 2016
Last Updated
July 1, 2018
Sponsor
Instituto Mexicano del Seguro Social
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1. Study Identification

Unique Protocol Identification Number
NCT02949674
Brief Title
Ropivacaine Versus Bupivacaine as Preemptive Analgesia in Surgical Site in Ankle Fracture Patients
Official Title
Ropivacaine Versus Bupivacaine as Preemptive Analgesia in Surgical Site in Ankle Fracture Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures, Pain, Postoperative, Local Infiltration

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Experimental
Arm Description
It will be used bupivacaine in surgical site prior surgery (25 mg). At least 10 minutes before skin incision.
Arm Title
Ropivacaine
Arm Type
Experimental
Arm Description
It will be used ropivacaine in surgical site prior surgery (37.5 mg). At least 10 minutes before skin incision.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No application of anesthetic
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
It will be used as a analgesic dose in surgical site before surgery.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Bupivacaine hydrochloride
Intervention Description
It will be used as a analgesic dose in surgical site before surgery.
Primary Outcome Measure Information:
Title
VAS
Description
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.
Time Frame
Change in Visual Analogue Scale at 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Jonathan De La Cruz Pacheco
Organizational Affiliation
IMSS
Official's Role
Study Chair
Facility Information:
Facility Name
UMAE Dr. Victorio de La Fuente Narvaez
City
Ciudad de Mexico
ZIP/Postal Code
07020
Country
Mexico

12. IPD Sharing Statement

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Ropivacaine Versus Bupivacaine as Preemptive Analgesia in Surgical Site in Ankle Fracture Patients

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