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

NCT02949674 | Completed Phase 3 Results

• 1 other identifier: R-2016-3401-55
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Fractures; Pain, Postoperative; Local Infiltration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Bupivacaine

EXPERIMENTAL

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

Drug: Bupivacaine

Ropivacaine

EXPERIMENTAL

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

Drug: Ropivacaine

Control

NO INTERVENTION

No application of anesthetic

Interventions

Ropivacaine DRUG

It will be used as a analgesic dose in surgical site before surgery.

Also known as: Naropin

Ropivacaine

Bupivacaine DRUG

It will be used as a analgesic dose in surgical site before surgery.

Also known as: Bupivacaine hydrochloride

Bupivacaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

UMAE Dr. Victorio de La Fuente Narvaez

Mexico City, 07020, Mexico

Location

MeSH Terms

Conditions

Ankle Fractures; Pain, Postoperative

Interventions

Ropivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

We consider that we can had a better result with higher dosis of local anesthetic, and the comparation with a placebo group would be a better analysis.

Results Point of Contact

• Title: Dr. Juan Lopez
• Organization: Instituto Mexicano del Seguro Social

juanlopez110@hotmail.com

+5257473500

Study Officials

• Juan Jonathan De La Cruz Pacheco

  IMSS

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 31, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: April 1, 2017
• Last Updated: December 31, 2018
• Results First Posted: December 31, 2018

Record last verified: 2017-09

Locations

ME (1)