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

• Sponsor: Instituto Mexicano del Seguro Social (Other)
• Overall Status: Completed
• CT.gov ID: NCT02949674
• Collaborator: (none)
• Enrollment: 93
• Location: 1
• Arms: 3
• Duration (Months): 7
• Patients Per Site Per Month: 13.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ankle Fractures; Pain, Postoperative; Local Infiltration	Drug: Ropivacaine; Drug: Bupivacaine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Ropivacaine Versus Bupivacaine as Preemptive Analgesia in Surgical Site in Ankle Fracture Patients
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. VAS [Change in Visual Analogue Scale at 24 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UMAE Dr. Victorio de La Fuente Narvaez	Ciudad de Mexico		Mexico	07020

Sponsors and Collaborators

• Instituto Mexicano del Seguro Social

Investigators

• Study Chair: Juan Jonathan De La Cruz Pacheco, IMSS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JUAN LOPEZ VALENCIA, Principal Investigator, Instituto Mexicano del Seguro Social
• ClinicalTrials.gov Identifier: NCT02949674
• Other Study ID Numbers: R-2016-3401-55
• First Posted: Oct 31, 2016
• Last Update Posted: Dec 31, 2018
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Pain, Postoperative; Fractures, Bone; Ankle Fractures; Bupivacaine; Ropivacaine

Study Results

Participant Flow

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

Arm/Group Title	Bupivacaine	Ropivacaine	Control
Arm/Group Description	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.	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.	No application of anesthetic
Period Title: Overall Study
STARTED	31	31	31
COMPLETED	31	31	31
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Bupivacaine	Ropivacaine	Control	Total
Arm/Group Description	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.	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.	No application of anesthetic	Total of all reporting groups
Overall Participants	31	31	31	93
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	42.3	37.16	33.71	37.7
Sex: Female, Male (Count of Participants)
Female	16 51.6%	18 58.1%	17 54.8%	51 54.8%
Male	15 48.4%	13 41.9%	14 45.2%	42 45.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Mexico	31 100%	31 100%	31 100%	93 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine	Ropivacaine	Control
Arm/Group Description	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.	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.	No application of anesthetic
Measure Participants	31	31	31
VAS at 4 hours	2.81 (1.302)	2.13 (0.619)	3.52 (1.387)
VAS at 8 hours	4.52 (1.022)	3.04 (1.113)	5.02 (0.957)
VAS at 12 hours	4.42 (0.765)	3.55 (0.995)	4.84 (1.061)
VAS at 24 hours	4.03 (0.836)	3.87 (0.783)	4.10 (0.831)

Adverse Events

Arm/Group Title	Bupivacaine		Ropivacaine		Control
Arm/Group Description	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.		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.		No application of anesthetic
All Cause Mortality
	Bupivacaine		Ropivacaine		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/31 (0%)		0/31 (0%)
Serious Adverse Events
	Bupivacaine		Ropivacaine		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/31 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Bupivacaine		Ropivacaine		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/31 (0%)		0/31 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.