NCT02586077

Foot and Ankle Clinic Application for Liposomal Related Anesthetic

Completed Phase 4 Results posted Last updated 29 October 2020

What this trial tests

Phase 4 trial testing Exparel in Ankle Arthrodesis in 36 participants. Completed in 15 November 2016.

Timeline

1 February 2014

Primary endpoint
30 June 2016

15 November 2016

Quick facts

Lead sponsor	OrthoCarolina Research Institute, Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	1 February 2014
Primary completion	30 June 2016
Estimated completion	15 November 2016
Sites	1 location across United States

Drugs / interventions tested

• Exparel — full drug profile →

Conditions studied

• Ankle Arthrodesis — all drugs for Ankle Arthrodesis →
• Hindfoot Arthrodesis — all drugs for Hindfoot Arthrodesis →
• Tibitalocalceal Arthrodesis — all drugs for Tibitalocalceal Arthrodesis →

Sponsor

OrthoCarolina Research Institute, Inc.

Who can join

18 and older, any sex, with Ankle Arthrodesis or Hindfoot Arthrodesis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Amount of Narcotic Use Primary · 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.

Group	Value	95% CI
Exparel	236.68	45 – 570

Visual Analog Scale of Pain (0-10) Secondary · 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

Post anesthesia care unit admission

Group	Value	95% CI
Exparel	0.96	0 – 10

Post anesthesia care unit discharge

Group	Value	95% CI
Exparel	0.86	0 – 6

Day of Surgery

Group	Value	95% CI
Exparel	2.36	0 – 7

Post-Operative Day 1

Group	Value	95% CI
Exparel	5.04	1 – 10

Post-operative Day 2

Group	Value	95% CI
Exparel	3.82	0 – 10

Post-operative Day 3

Group	Value	95% CI
Exparel	4.29	0 – 9

Anti-emetic Use Secondary · 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).

Group	Value	95% CI
Overall	19
Overall	9

Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief Secondary · 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

Group	Value	95% CI
Overall	3
Overall	3
Overall	4
Overall	6

Number of Patients With Post-operative Complications Secondary · 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.

Group	Value	95% CI
Overall	27
Overall	1

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Overall

Serious: 1/36 (3%)

Deaths: 0/36

Serious adverse events (1 terms)

Reaction	System	Overall
Increased pain	General disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Overall
superficial cellulitis	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Increased pain.

Data from ClinicalTrials.gov NCT02586077 adverse events section.

Sponsor's own description

The purpose of this study is to review the use of surgeon applied liposomal release anesthetic (Exparel) for post operative analgesia.

Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post operative analgesia. Immediated and 72 hour narcotic use will be significantly impacted by the use of this modality.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.