Trial Outcomes & Findings for Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures (NCT NCT02967172)
NCT ID: NCT02967172
Last Updated: 2023-12-15
Results Overview
The primary outcome was VAS pain over the first 48 hours postoperatively. Patients reported pain with use of a 100-mm VAS, with 0-mm being no pain and 100-mm being the most extreme pain imaginable. A higher score indicates worse pain. Scores were reported as mean values at 24 hours post-surgery and 48 hours post-surgery.
COMPLETED
PHASE4
100 participants
Immediately following surgery, then every 4 hours following surgery for 48 hours post-surgery.
2023-12-15
Participant Flow
Participant milestones
| Measure |
Peri-incisional Injection
* 20 mL injected into the peri-incisional soft tissues in a circumferential fashion
* 5mL injected into the ankle joint This cocktail includes 200 mg of 0.8% ropivacaine, 0.6 mg of epinephrine, 5 mg of morphine sulfate, and 0.9% sodium chloride solution.
|
Control
No peri-incisional injection will be completed during surgical fixation/instrumentation
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
COMPLETED
|
49
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Peri-incisional Injection
n=49 Participants
A single, 25 cc multimodal analgesic cocktail will be injected following completion of ankle fracture fixation/instrumentation while the patient remains under general anesthesia and prior to skin closure. The injection will be administered as such:
* 20 mL injected into the peri-incisional soft tissues in a circumferential fashion
* 5mL injected into the ankle joint This cocktail includes 200 mg of 0.8% ropivacaine, 0.6 mg of epinephrine, 5 mg of morphine sulfate, and sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.
Interventions:
Drug: Ropivacaine Drug: Epinephrine Drug: Morphine Drug: 0.9% sodium chloride solution Following surgery, patients in the treatment and non-treatment groups will both be provided with the same intravenous (patient-controlled analgesia) and oral pain medications scheduled "per needed".
Ropivacaine
Epinephrine
Morphine
0.9% sodium chloride solution
|
Control
n=51 Participants
Ankle fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age range
|
40 years
n=49 Participants
|
41 years
n=51 Participants
|
40 years
n=100 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=49 Participants
|
30 Participants
n=51 Participants
|
60 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=49 Participants
|
21 Participants
n=51 Participants
|
40 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Age
|
45.4 years
STANDARD_DEVIATION 17.6 • n=49 Participants
|
43.7 years
STANDARD_DEVIATION 17.6 • n=51 Participants
|
44.6 years
STANDARD_DEVIATION 17.6 • n=100 Participants
|
PRIMARY outcome
Timeframe: Immediately following surgery, then every 4 hours following surgery for 48 hours post-surgery.The primary outcome was VAS pain over the first 48 hours postoperatively. Patients reported pain with use of a 100-mm VAS, with 0-mm being no pain and 100-mm being the most extreme pain imaginable. A higher score indicates worse pain. Scores were reported as mean values at 24 hours post-surgery and 48 hours post-surgery.
Outcome measures
| Measure |
Peri-incisional Injection
n=49 Participants
* 20 mL injected into the peri-incisional soft tissues in a circumferential fashion
* 5mL injected into the ankle joint This cocktail includes 200 mg of 0.8% ropivacaine, 0.6 mg of epinephrine, 5 mg of morphine sulfate, and 0.9% sodium chloride solution. .
|
Control
n=51 Participants
Ankle fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
|
|---|---|---|
|
Change in Post-operative Visual Analog Pain Scores (VAS)
Mean VAS score 24hr post-op
|
42 0 to 100 score on a scale
Standard Deviation 3
|
52 0 to 100 score on a scale
Standard Deviation 3
|
|
Change in Post-operative Visual Analog Pain Scores (VAS)
Mean VAS score 48hr post-op
|
41 0 to 100 score on a scale
Standard Deviation 3
|
50 0 to 100 score on a scale
Standard Deviation 3
|
SECONDARY outcome
Timeframe: At 24 hours post-surgery & during the total time of inpatient stay to dischageTotal opioid consumption expressed in morphine equivalent dose will be recorded, including IV and oral opioids, in the first 24 hours post-surgery.
Outcome measures
| Measure |
Peri-incisional Injection
n=49 Participants
* 20 mL injected into the peri-incisional soft tissues in a circumferential fashion
* 5mL injected into the ankle joint This cocktail includes 200 mg of 0.8% ropivacaine, 0.6 mg of epinephrine, 5 mg of morphine sulfate, and 0.9% sodium chloride solution. .
|
Control
n=51 Participants
Ankle fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
|
|---|---|---|
|
Opioid Use in First 24 Hours Post-surgery
Opioid use 24hr post-surgery
|
25.5 Milligrams
Interval 0.0 to 74.7
|
28.3 Milligrams
Interval 2.5 to 91.0
|
|
Opioid Use in First 24 Hours Post-surgery
Total inpatient opioid use
|
29.0 Milligrams
Interval 0.0 to 85.3
|
32.7 Milligrams
Interval 4.3 to 215.0
|
SECONDARY outcome
Timeframe: From immediately following surgery to 90 days after.Number of days in the hospital following surgery
Outcome measures
| Measure |
Peri-incisional Injection
n=49 Participants
* 20 mL injected into the peri-incisional soft tissues in a circumferential fashion
* 5mL injected into the ankle joint This cocktail includes 200 mg of 0.8% ropivacaine, 0.6 mg of epinephrine, 5 mg of morphine sulfate, and 0.9% sodium chloride solution. .
|
Control
n=51 Participants
Ankle fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
|
|---|---|---|
|
Post-operative Length of Stay
|
22.3 Hours
Interval 1.7 to 182.3
|
22.5 Hours
Interval 2.2 to 123.3
|
SECONDARY outcome
Timeframe: Following hospital discharge from surgeryNumber of patients returning to their home following discharge, vs. going to a rehabilitation or skilled nursing facility
Outcome measures
| Measure |
Peri-incisional Injection
n=49 Participants
* 20 mL injected into the peri-incisional soft tissues in a circumferential fashion
* 5mL injected into the ankle joint This cocktail includes 200 mg of 0.8% ropivacaine, 0.6 mg of epinephrine, 5 mg of morphine sulfate, and 0.9% sodium chloride solution. .
|
Control
n=51 Participants
Ankle fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
|
|---|---|---|
|
Patients Returning Home Following Surgery
|
49 Participants
|
46 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From immediately following surgery to 7 days after.Patients will be monitored by nursing personnel for medication side effects related to ropivacaine toxicity including blurred vision, hearing problems, transient peripheral paralysis, dizziness, convulsion, uncontrolled muscle contraction, hypotension, bradycardia, and new onset arrhythmia.
Outcome measures
Outcome data not reported
Adverse Events
Peri-incisional Injection
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place