Skip to content

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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02949674
Enrollment
93
Registered
2016-10-31
Start date
2016-09-30
Completion date
2017-04-30
Last updated
2018-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fractures, Local Infiltration, Pain, Postoperative

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.

Interventions

DRUGRopivacaine

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

DRUGBupivacaine

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

Sponsors

Instituto Mexicano del Seguro Social
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
VASChange in Visual Analogue Scale at 24 hoursThe Pain will be measured with this scale from 0 (No pain) -10 (Worst pain possible) according to the investigator at 24 hours after surgery.

Countries

Mexico

Participant flow

Recruitment details

Recruitment dates: January 2017 to April 2017, at High Specialty Unit Dr. Victorio de la Fuente Narvaez, IMSS

Participants by arm

ArmCount
Bupivacaine
It will be used bupivacaine in surgical site prior surgery (25 mg). At least 10 minutes before skin incision. Bupivacaine: It will be used as a analgesic dose in surgical site before surgery.
31
Ropivacaine
It will be used ropivacaine in surgical site prior surgery (37.5 mg). At least 10 minutes before skin incision. Ropivacaine: It will be used as a analgesic dose in surgical site before surgery.
31
Control
No application of anesthetic
31
Total93

Baseline characteristics

CharacteristicBupivacaineRopivacaineControlTotal
Age, Continuous42.3 years37.16 years33.71 years37.7 years
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Mexico
31 participants31 participants31 participants93 participants
Sex: Female, Male
Female
16 Participants18 Participants17 Participants51 Participants
Sex: Female, Male
Male
15 Participants13 Participants14 Participants42 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 310 / 31
other
Total, other adverse events
0 / 310 / 310 / 31
serious
Total, serious adverse events
0 / 310 / 310 / 31

Outcome results

Primary

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.

Time frame: Change in Visual Analogue Scale at 24 hours

ArmMeasureGroupValue (MEAN)Dispersion
BupivacaineVASVAS at 4 hours2.81 units on a scale (VAS)Standard Deviation 1.302
BupivacaineVASVAS at 8 hours4.52 units on a scale (VAS)Standard Deviation 1.022
BupivacaineVASVAS at 12 hours4.42 units on a scale (VAS)Standard Deviation 0.765
BupivacaineVASVAS at 24 hours4.03 units on a scale (VAS)Standard Deviation 0.836
RopivacaineVASVAS at 24 hours3.87 units on a scale (VAS)Standard Deviation 0.783
RopivacaineVASVAS at 4 hours2.13 units on a scale (VAS)Standard Deviation 0.619
RopivacaineVASVAS at 12 hours3.55 units on a scale (VAS)Standard Deviation 0.995
RopivacaineVASVAS at 8 hours3.04 units on a scale (VAS)Standard Deviation 1.113
ControlVASVAS at 24 hours4.10 units on a scale (VAS)Standard Deviation 0.831
ControlVASVAS at 8 hours5.02 units on a scale (VAS)Standard Deviation 0.957
ControlVASVAS at 12 hours4.84 units on a scale (VAS)Standard Deviation 1.061
ControlVASVAS at 4 hours3.52 units on a scale (VAS)Standard Deviation 1.387

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026