A Study of Postsurgical Pain Control for Lower Extremity Fractures

NCT02214810 | Withdrawn Phase 1 DMC

• 1 other identifier: 5187
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Fractures.

Keywords

Bupivacaine; multimodal; exparel; open reduction; internal fixation; post-surgical pain control

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Pain Management Satisfaction

  2 weeks, post-operatively

Study Arms (2)

Control- Marcain

ACTIVE COMPARATOR

Group 1 will receive non-liposomal bupivacaine introduced into the soft tissue surrounding the fracture at the conclusion of the surgery.

Drug: Bupivacaine/Exparel

Experimental- Exparel

EXPERIMENTAL

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.

Drug: Bupivacaine/Exparel

Interventions

Bupivacaine/Exparel DRUG

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.

Control- Marcain; Experimental- Exparel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Broward Health: lead

Study Sites (1)

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Related 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 J 2001

  RESULT

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Brian J Cross, MD

  Broward Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 12, 2014
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

US (1)