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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02499575
Other study ID # OH2-15-0005
Secondary ID
Status Terminated
Phase N/A
First received July 2, 2015
Last updated July 25, 2016
Start date July 2015
Est. completion date July 2016

Study information

Verified date July 2016
Source OhioHealth
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In this study the investigators plan to determine the ability of Exparel to control post-operative pain in common first metatarsophalangeal (MTP) joint procedures (bunion surgery, 1st MTP fusion, and cheilectomy).


Description:

The investigators propose a prospective, randomized, single-blinded study of patients who are electing to undergo an outpatient first metatarsophalangeal (MTP) joint procedure (bunionectomy, 1st MTP fusion, or cheilectomy). As a standard, patients undergoing these procedures are given regional anesthesia (adductor canal block plus popliteal block). Patients are then given prescriptions for oral opioids to manage post-operative pain. The purpose of this study is to determine whether a single intrapopliteal administration of Exparel, in conjunction with the standard of care regional block, improves pain relief and therefore decreases use of post-operative opioids.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date July 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age = 18

- Undergoing distal or midshaft osteotomy for bunion correction, 1st MTP Fusion, or cheilectomy

Exclusion Criteria:

- Age less than 18

- Unable to read/write English

- Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting

- Weight <70 kg

- Allergy to local anesthetics

- History of long-acting opioid use or opioid tolerance (any patient receiving at least 30 mg of oxycodone or equivalent per day (e.g., 6 tabs of Percocet 5/325 mg) regularly for approximately 7 days or more OR who require increased analgesic doses for a period long enough to develop tolerance to the effects of the opioid including analgesia and sedation)

- Any history of opioid misuse, illicit or prescription

- Prior MTP joint correction on the surgical limb

- Midfoot and hindfoot procedures performed concurrently, on the same day

- Pregnant or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
0.5% ropivacaine
Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Exparel
106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)

Locations

Country Name City State
United States Grant Medical Center Columbus Ohio
United States Orthopedic Foot and Ankle Center Westerville Ohio

Sponsors (1)

Lead Sponsor Collaborator
OhioHealth

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid Use as Measured by Questionnaire Compare time to first opioid use and total opioid use (reported as total morphine equivalents) over 72 hours between groups Daily through the third day (72 hours) post-surgery No
Secondary Pain Relief Measured by Defense and Veterans Pain Scale Evaluate patient-reported pain scores (scale of 1-10) at 0, 6, 12, 24, 36, 48, 60, and 72 hours following surgery Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery) No
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