Clinical trial NCT02214810: A Study of Postsurgical Pain Control for Lower Extremity Fractures
Official title: A Randomized, Single-blinded, Prospective Study of Postsurgical Pain Control After Open Reduction and Internal Fixation of Lower Extremity Fractures With Liposomal Marcaine.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Lower Extremity Fractures.
Keywords: Bupivacaine
multimodal
exparel
open reduction
internal fixation
post-surgical pain control
Lead sponsor: Broward Health
Sponsor class: OTHER
First posted: 2014-08-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postsurgical pain may effectively be treated with a multimodal approach that incorporates the use of local anesthetics. Bupivacaine is a local anesthetic that has been proven to be effective at reducing postsurgical pain. Furthermore, this local anesthetic has been shown to reduce opioid use, improve functional outcomes, allow for early mobilization, and decrease hospital length of stay. However, local anesthetics, via wound infiltration, are often short-acting and do not meet the duration of postsurgical pain due to their solubility and protein-binding properties. ExparelTM is an FDA-approved liposomal formulation of bupivacaine that allows for 72 hours of postsurgical analgesia with a single injection. This formulation has been shown to have little to no adverse effects; although some studies have reported adverse effects with the use of ExaprelTM, most frequently being nausea, vomiting, and dizziness. The occurrences of these adverse events were still less than the placebo cohort.

Detailed description: All patients undergoing surgical fixation of a lower extremity fracture(s) will be offered the opportunity to enroll in the study. Patients undergoing unilateral or bilateral surgical fixation would be included. Written, informed consent to enrollment will be recorded and included in the patient record. The study is designed around the standard of care for postsurgical pain management. There are no additional costs to the patient strictly related to this study.

Patients will undergo surgical fixation of a lower extremity fracture(s) by one of surgical investigators at a single institution. A sealed, opaque envelope, selected in the pre-operative holding area, will accompany each patient participant to the operating room. The envelope will be opened at the conclusion of the fracture fixation to reveal patient assignment to either study Group 1 or Group 2. Once the total numbers of patients have completed their procedures and follow-up, the study will close.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Preoperative diagnosis of lower extremity fracture(s) requiring surgical fixation

Exclusion Criteria:

* Allergy to ExparelTM or certain other local anesthetic agents
* Surgery performed at an outside institution or by a different surgeon
* Chronic analgesic users (defined as use of opioid medication \>14 days in the past 3 months, or use of non-opioid pain medication \>5 times per week
* Pregnant females or females who think they may become pregnant
* Peripheral neuropathy
* Major psychiatric disease
* Inability to comprehend the nature of the study
* Unwillingness to provide signed informed consent
* Markedly abnormal kidney function or renal disease
* Non-English speaking
* Signs or symptoms of compartment syndrome

Primary outcomes:
measure: Change in Pain Visual Analogue Scale (VAS)
timeFrame: 72 hours
Secondary outcomes:
measure: Pain Management Satisfaction
timeFrame: 2 weeks, post-operatively
Other outcomes:
Locations:
city: Ft. Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
Study officials:
affiliation: Broward Health
name: Brian J Cross, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: References 1-Candoitti 2012 2-Gupta Curr Opin Anaesthesiol 2010, Liu J Am Coll Surg 2006 3-Lynch Anesth Analg 1997, Amin J Surg Pakistan 2010 4-Golf Adv Ther 2011, Onel 2011, Bergese IARS Annual Meeting 2011 5-Angst Clin Pharmacokinet 2006, Howell Cancer J 2001