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A Study of Postsurgical Pain Control for Lower Extremity Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214810
Recruitment Status : Withdrawn
First Posted : August 12, 2014
Last Update Posted : February 19, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lower Extremity Fractures. Drug: Bupivacaine/Exparel Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : January 2015
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control- Marcain
Group 1 will receive non-liposomal bupivacaine introduced into the soft tissue surrounding the fracture at the conclusion of the surgery.
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.

Experimental: Experimental- 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.
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.




Primary Outcome Measures :
  1. Change in Pain Visual Analogue Scale (VAS) [ Time Frame: 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 :
  1. Pain Management Satisfaction [ Time Frame: 2 weeks, post-operatively ]
    Patients will complete the post-surgery satisfaction form at their 2-week, post-operative office visit.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214810


Locations
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United States, Florida
Broward Health Medical Center
Ft. Lauderdale, Florida, United States, 33316
Sponsors and Collaborators
Broward Health
Investigators
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Principal Investigator: Brian J Cross, MD Broward Health

Publications of Results:
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

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Responsible Party: Broward Health
ClinicalTrials.gov Identifier: NCT02214810    
Other Study ID Numbers: 5187
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016
Keywords provided by Broward Health:
Bupivacaine
multimodal
exparel
open reduction
internal fixation
post-surgical pain control
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents