Trial Outcomes & Findings for Foot and Ankle Clinic Application for Liposomal Related Anesthetic (NCT NCT02586077)

Results Overview

Total morphine milligram equivalence dosing of all narcotic pain medications administered between the surgery and the third post-operative day.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

Surgery to post operative day 3

Results posted on

2020-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Exparel Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case.
Overall Study STARTED	36
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Exparel Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case.
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	4
Overall Study Lost to Follow-up	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exparel n=28 Participants Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case.
Age, Continuous	55.6 years n=28 Participants
Sex: Female, Male Female	18 Participants n=28 Participants
Sex: Female, Male Male	10 Participants n=28 Participants
Region of Enrollment United States	28 participants n=28 Participants

PRIMARY outcome

Timeframe: Surgery to post operative day 3

Total morphine milligram equivalence dosing of all narcotic pain medications administered between the surgery and the third post-operative day.

Outcome measures

Outcome measures
Measure	Exparel n=28 Participants Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case.
Amount of Narcotic Use	236.68 mg Interval 45.0 to 570.0

SECONDARY outcome

Timeframe: Post anesthesia care unit admission to post operative day 3

Visual Analog Scale (VAS) of pain (0-10); with 10 indicating the greatest amount of pain. Post anesthesia care unit admission, post anesthesia care unit discharge, day of surgery, post operative day 1, post operative day 2, post operative day 3

Outcome measures

Outcome measures
Measure	Exparel n=28 Participants Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case.
Visual Analog Scale of Pain (0-10) Post anesthesia care unit admission	0.96 units on a scale Interval 0.0 to 10.0
Visual Analog Scale of Pain (0-10) Post anesthesia care unit discharge	0.86 units on a scale Interval 0.0 to 6.0
Visual Analog Scale of Pain (0-10) Day of Surgery	2.36 units on a scale Interval 0.0 to 7.0
Visual Analog Scale of Pain (0-10) Post-Operative Day 1	5.04 units on a scale Interval 1.0 to 10.0
Visual Analog Scale of Pain (0-10) Post-operative Day 2	3.82 units on a scale Interval 0.0 to 10.0
Visual Analog Scale of Pain (0-10) Post-operative Day 3	4.29 units on a scale Interval 0.0 to 9.0

SECONDARY outcome

Timeframe: After surgery through discharge from hospital, usually 72 hours after surgery (on post operative day 3)

Anti-emetic use (as a binary yes/no) between the admission in the post anesthesia care unit through hospital discharge (i.e. if a patient took an anti-emetic at any point duration the time frame the patient was a yes; if the patient did not take an anti-emetic during the time frame the patient was a no).

Outcome measures

Outcome measures
Measure	Exparel n=28 Participants Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case.
Anti-emetic Use No	19 Participants
Anti-emetic Use Yes	9 Participants

SECONDARY outcome

Timeframe: Measured at hospital discharge (on post operative day 3)

Measured at hospital discharge (on post operative day 3). Measured on a scale of 1-5, with 5 being the most satisfaction

Outcome measures

Outcome measures
Measure	Exparel n=28 Participants Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case.
Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief 1	3 Participants
Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief 2	3 Participants
Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief 3	4 Participants
Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief 4	6 Participants
Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief 5	12 Participants

SECONDARY outcome

Timeframe: After surgery to the first scheduled clinic visit, usually 14 days after surgery

Any complications occurring between the day of surgery and the first scheduled appointment at our clinic after the surgery.

Outcome measures

Outcome measures
Measure	Exparel n=28 Participants Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case.
Number of Patients With Post-operative Complications No	27 Participants
Number of Patients With Post-operative Complications Yes	1 Participants

Adverse Events

Overall

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Overall n=36 participants at risk Data across all patients
General disorders Increased pain	2.8% 1/36 • Number of events 1

Other adverse events

Other adverse events
Measure	Overall n=36 participants at risk Data across all patients
Skin and subcutaneous tissue disorders superficial cellulitis	2.8% 1/36 • Number of events 1

Additional Information

Susan Odum

OrthoCarolina Research Institute

Phone: 7049457710

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place