Trial Outcomes & Findings for Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures (NCT NCT02793947)

Last Updated: 2018-04-05

Results Overview

Patients will describe their current level of comfort on a 10 point scale while at rest. Zero corresponds to "no pain" and ten corresponds to "the most extreme possible pain." Visual analog scores will be collected by nursing staff who are blinded to the treatment allocation.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

102 participants

Primary outcome timeframe

Pain assessment will be collected immediately prior to surgery (pre-op), immediately following surgery in the post-anesthesia care unit (PACU), and every 4 hours following surgery for the first two post-operative days (48 hours total; 4H-48H)

Results posted on

2018-04-05

Participant Flow

Participant milestones

Participant milestones
Measure	Peri-incisional Injection A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.	Control (no Injection) Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
Overall Study STARTED	47	55
Overall Study COMPLETED	45	50
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Peri-incisional Injection A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.	Control (no Injection) Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
Overall Study Death	1	0
Overall Study Physician Decision	1	5

Baseline Characteristics

Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peri-incisional Injection n=47 Participants A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.	Control (no Injection) n=55 Participants Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=45 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).	0 Participants n=50 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).	0 Participants n=95 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).
Age, Categorical Between 18 and 65 years	8 Participants n=45 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).	15 Participants n=50 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).	23 Participants n=95 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).
Age, Categorical >=65 years	37 Participants n=45 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).	35 Participants n=50 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).	72 Participants n=95 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).
Age, Continuous	72.8 years STANDARD_DEVIATION 15.2 • n=45 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).	70.0 years STANDARD_DEVIATION 15.2 • n=50 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).	71.4 years STANDARD_DEVIATION 15.2 • n=95 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).
Sex: Female, Male Female	29 Participants n=45 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).	36 Participants n=50 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).	65 Participants n=95 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).
Sex: Female, Male Male	16 Participants n=45 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).	14 Participants n=50 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).	30 Participants n=95 Participants • Although 102 subjects were randomized into the study, seven patients (2 in the injection group and 5 in the control group) were excluded following randomization because of early postoperative mortality (n = 1) and postoperative delirium (n = 6).
Region of Enrollment United States	47 participants n=47 Participants	55 participants n=55 Participants	102 participants n=102 Participants

PRIMARY outcome

Timeframe: Pain assessment will be collected immediately prior to surgery (pre-op), immediately following surgery in the post-anesthesia care unit (PACU), and every 4 hours following surgery for the first two post-operative days (48 hours total; 4H-48H)

Outcome measures

Outcome measures
Measure	Peri-incisional Injection n=45 Participants A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.	Control (no Injection) n=50 Participants Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
Visual Analog Scale Pain Assessment Pre-op	5.0 units on a scale Interval 3.0 to 7.0	5.0 units on a scale Interval 2.0 to 7.0
Visual Analog Scale Pain Assessment PACU	1.6 units on a scale Interval 0.0 to 4.0	3.2 units on a scale Interval 1.3 to 5.7
Visual Analog Scale Pain Assessment 4H	1.0 units on a scale Interval 0.0 to 3.0	5.0 units on a scale Interval 2.0 to 7.0
Visual Analog Scale Pain Assessment 8H	2.0 units on a scale Interval 0.0 to 4.0	5.0 units on a scale Interval 2.0 to 6.8
Visual Analog Scale Pain Assessment 12H	3.5 units on a scale Interval 0.0 to 5.0	5.0 units on a scale Interval 2.0 to 8.0
Visual Analog Scale Pain Assessment 16H	3.5 units on a scale Interval 2.0 to 5.8	4.0 units on a scale Interval 2.8 to 6.0
Visual Analog Scale Pain Assessment 20H	4.0 units on a scale Interval 2.0 to 6.0	4.0 units on a scale Interval 2.0 to 5.8
Visual Analog Scale Pain Assessment 24H	3.0 units on a scale Interval 2.0 to 5.8	4.0 units on a scale Interval 3.0 to 6.0
Visual Analog Scale Pain Assessment 28H	3.0 units on a scale Interval 0.8 to 5.0	3.5 units on a scale Interval 2.0 to 5.0
Visual Analog Scale Pain Assessment 32H	3.0 units on a scale Interval 1.0 to 4.0	5.0 units on a scale Interval 3.0 to 6.0
Visual Analog Scale Pain Assessment 36H	4.0 units on a scale Interval 1.0 to 5.0	4.0 units on a scale Interval 2.0 to 5.0
Visual Analog Scale Pain Assessment 40H	3.0 units on a scale Interval 2.0 to 5.0	3.5 units on a scale Interval 2.0 to 5.0
Visual Analog Scale Pain Assessment 44H	3.0 units on a scale Interval 0.0 to 5.0	4.0 units on a scale Interval 2.0 to 5.0
Visual Analog Scale Pain Assessment 48H	3.0 units on a scale Interval 1.0 to 5.0	3.0 units on a scale Interval 2.0 to 4.8

SECONDARY outcome

Timeframe: Narcotic consumption will be recorded every 8 hours for the first two post-operative days.

Parenteral and oral narcotic agents will be utilized by patients for post-operative pain control per the standard of care. No alterations in narcotic prescription behavior will be observed for this study.

Outcome measures

Outcome measures
Measure	Peri-incisional Injection n=45 Participants A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.	Control (no Injection) n=50 Participants Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
Total Narcotic Consumption	5.0 mg of morphine Interval 1.3 to 8.0	9.7 mg of morphine Interval 3.9 to 15.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 hours following surgery

Patients will be monitored every 15 minutes in the recovery room and every 4 hours for the first two post-operative days 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 measures
Measure	Peri-incisional Injection n=45 Participants A 100 cc multimodal analgesic cocktail will be injected into the superficial and deep peri-incisional tissues after the completion of femur fracture fixation/instrumentation while the patient remains under general anesthesia and prior to wound closure. This cocktail includes 400 mg of 0.75% ropivacaine (53.33 mL), 0.6 mg of 1 mg/mL epinephrine (0.6 mL), 5 mg of 0.5 mg/mL morphine sulfate (10 mL), and 36.07 mL 0.9% sodium chloride solution. All infiltrations will be completed with a blunt trochar to minimize the risk of intravascular injection.	Control (no Injection) n=50 Participants Femur fracture fixation/instrumentation will be completed per the standard of care. No peri-incisional injection will be completed.
Number of Participants With Medication-related Side Effects	0 Participants	0 Participants

Adverse Events

Peri-incisional Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Control (no Injection)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Willey

University of Iowa Hospitals and Clinics

Phone: 319-384-8452

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place