A Study of Postsurgical Pain Control for Lower Extremity Fractures

Phase 1

Withdrawn

• Conditions: Lower Extremity Fractures.
• Interventions: Drug: Bupivacaine/Exparel

• Registration Number: NCT02214810
• Lead Sponsor: Broward Health

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.

Study Timeline

• Study First Submitted: 2014-08-08
• Study First Submitted QC: 2014-08-11
• Study First Posted: 2014-08-12
• Study Start: 2015-01
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control- Marcain	Bupivacaine/Exparel	Group 1 will receive non-liposomal bupivacaine introduced into the soft tissue surrounding the fracture at the conclusion of the surgery.
Experimental- Exparel	Bupivacaine/Exparel	Group 2 will receive a mixture of non-liposomal bupivacaine and Exparel introduced into the soft tissue surrounding the fracture at the conclusion of the surgery.

Primary Outcome Measures

Name	Time	Method
Change in Pain Visual Analogue Scale (VAS)	72 hours	Patients will be asked to complete a Pain Visual Analogue Scale every 2 hours for the first 12 hours of their stay (2, 4, 6, 8, 10, 12), and then again at 24, 30 and 72 hours into their hospitalization.

Secondary Outcome Measures

Name	Time	Method
Pain Management Satisfaction	2 weeks, post-operatively	Patients will complete the post-surgery satisfaction form at their 2-week, post-operative office visit.

Trial Locations

Locations (1)

Broward Health Medical Center; 🇺🇸 Ft. Lauderdale, Florida, United States