Foot and Ankle Clinic Application for Liposomal Related Anesthetic

• Sponsor: OrthoCarolina Research Institute, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT02586077
• Collaborator: Pacira Pharmaceuticals, Inc (Industry)
• Enrollment: 36
• Location: 1
• Arm: 1
• Duration (Months): 33.4
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ankle Arthrodesis; Hindfoot Arthrodesis; Tibitalocalceal Arthrodesis	Drug: Exparel	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Foot and Ankle Clinic Application for Liposomal Related Anesthetic
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Jun 30, 2016
• Actual Study Completion Date: Nov 15, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Exparel

Outcome Measures

Primary Outcome Measures

1. Amount of Narcotic Use [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.

Secondary Outcome Measures

1. Visual Analog Scale of Pain (0-10) [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

2. Anti-emetic Use [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).

3. Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief [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

4. Number of Patients With Post-operative Complications [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Any patient scheduled for ankle arthrodesis, a tibiotalocalcaneal arthrodesis, hindfoot arthrodesis including subtalar, double, triple, or isolated talonavicular arthrodesis

• Patients over the age of 18

• The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study

Exclusion Criteria:

• < 18 years of age

• Patients with a history of infection

• Patients diagnosed with neuropathy or any form of numbness or loss of feeling in the arms or legs due to damaged nerves

• Patients having surgery on both feet at the same time

• Patients having any other different type of foot and ankle surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OrthoCarolina, PA	Charlotte	North Carolina	United States	28203

Sponsors and Collaborators

• OrthoCarolina Research Institute, Inc.
• Pacira Pharmaceuticals, Inc

Investigators

• Study Director: Susan M Odum, PhD, OrthoCarolina Research Institute
• Principal Investigator: Bruce Cohen, MD, OrthoCarolina Foot & Ankle Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: OrthoCarolina Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT02586077
• Other Study ID Numbers: 12-13-12E
• First Posted: Oct 26, 2015
• Last Update Posted: Oct 29, 2020
• Last Verified: Oct 1, 2020

Study Results

Participant Flow

Arm/Group Title	Exparel
Arm/Group Description	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.
Period Title: Overall Study
STARTED	36
COMPLETED	28
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Exparel
Arm/Group Description	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 Participants	28
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	55.6
Sex: Female, Male (Count of Participants)
Female	18 64.3%
Male	10 35.7%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	28 100%

Outcome Measures

1. Primary Outcome

Title	Amount of Narcotic Use
Description	Total morphine milligram equivalence dosing of all narcotic pain medications administered between the surgery and the third post-operative day.
Time Frame	Surgery to post operative day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exparel
Arm/Group Description	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.
Measure Participants	28
Mean (Full Range) [mg]	236.68

2. Secondary Outcome

Title	Visual Analog Scale of Pain (0-10)
Description	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
Time Frame	Post anesthesia care unit admission to post operative day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exparel
Arm/Group Description	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.
Measure Participants	28
Post anesthesia care unit admission	0.96
Post anesthesia care unit discharge	0.86
Day of Surgery	2.36
Post-Operative Day 1	5.04
Post-operative Day 2	3.82
Post-operative Day 3	4.29

3. Secondary Outcome

Title	Anti-emetic Use
Description	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).
Time Frame	After surgery through discharge from hospital, usually 72 hours after surgery (on post operative day 3)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall
Arm/Group Description	Data across all patients
Measure Participants	28
No	19 67.9%
Yes	9 32.1%

4. Secondary Outcome

Title	Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief
Description	Measured at hospital discharge (on post operative day 3). Measured on a scale of 1-5, with 5 being the most satisfaction
Time Frame	Measured at hospital discharge (on post operative day 3)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall
Arm/Group Description	Data across all patients
Measure Participants	28
1	3 10.7%
2	3 10.7%
3	4 14.3%
4	6 21.4%
5	12 42.9%

5. Secondary Outcome

Title	Number of Patients With Post-operative Complications
Description	Any complications occurring between the day of surgery and the first scheduled appointment at our clinic after the surgery.
Time Frame	After surgery to the first scheduled clinic visit, usually 14 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall
Arm/Group Description	Data across all patients
Measure Participants	28
No	27 96.4%
Yes	1 3.6%

Adverse Events

Arm/Group Title	Overall
Arm/Group Description	Data across all patients
All Cause Mortality
	Overall
	Affected / at Risk (%)	# Events
Total	0/36 (0%)
Serious Adverse Events
	Overall
	Affected / at Risk (%)	# Events
Total	1/36 (2.8%)
General disorders
Increased pain	1/36 (2.8%)	1
Other (Not Including Serious) Adverse Events
	Overall
	Affected / at Risk (%)	# Events
Total	1/36 (2.8%)
Skin and subcutaneous tissue disorders
superficial cellulitis	1/36 (2.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.