Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Experimental | It will be used bupivacaine in surgical site prior surgery (25 mg). At least 10 minutes before skin incision. |
|
| Ropivacaine | Experimental | It will be used ropivacaine in surgical site prior surgery (37.5 mg). At least 10 minutes before skin incision. |
|
| Control | No Intervention | No application of anesthetic |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | It will be used as a analgesic dose in surgical site before surgery. |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Juan Jonathan De La Cruz Pacheco | IMSS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMAE Dr. Victorio de La Fuente Narvaez | Mexico City | 07020 | Mexico |
Not provided
Recruitment dates: January 2017 to April 2017, at High Specialty Unit Dr. Victorio de la Fuente Narvaez, IMSS
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Control | No application of anesthetic |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Ropivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale (VAS) | Change in Visual Analogue Scale at 24 hours |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Juan Lopez | Instituto Mexicano del Seguro Social | +5257473500 | 25538 | juanlopez110@hotmail.com |
Not provided
| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bupivacaine | Drug | It will be used as a analgesic dose in surgical site before surgery. |
|
|
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.
| BG002 | Control | No application of anesthetic |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Control | No application of anesthetic |
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | 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. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG002 | Control | No application of anesthetic | 0 | 31 | 0 | 31 | 0 | 31 |
Not provided
Not provided
Not provided
| D011183 |
| Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| Male |
|