A Study of Postsurgical Pain Control for Lower Extremity Fractures

Lower Extremity Fractures. Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02214810
• Other study ID #: 5187
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: August 8, 2014
• Last updated: February 18, 2016
• Start date: January 2015
• Est. completion date: September 2015

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Lower Extremity Fractures.

Intervention

Drug:
• Bupivacaine/Exparel
The opaque envelope, which was selected by the treating physician, will accompany each of the study participants will be opened and the patient identified as belonging to either Group 1 or Group 2. It is important to note that randomization of the envelopes were computer-generated and placed by a co-investigator; the treating physician is completely unaware of the order of the opaque envelopes. Patients in Group 1 will receive a standardized medication regimen including non-liposomal bupivacaine by soft-tissue injection at the conclusion of their surgical procedure. Those in Group 2 will receive non-liposomal bupivacaine and ExparelTM by soft-tissue injection at the conclusion of their surgical procedure. Study participants will undergo injection in this manner until the conclusion of the study.

Locations

Country	Name	City	State
United States	Broward Health Medical Center	Ft. Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Broward Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Visual Analogue Scale (VAS)	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.	72 hours	Yes
Secondary	Pain Management Satisfaction	Patients will complete the post-surgery satisfaction form at their 2-week, post-operative office visit.	2 weeks, post-operatively	No