A Study of Postsurgical Pain Control for Lower Extremity Fractures
| Status: | Withdrawn |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2015 |
| End Date: | September 2015 |
A Randomized, Single-blinded, Prospective Study of Postsurgical Pain Control After Open Reduction and Internal Fixation of Lower Extremity Fractures With Liposomal Marcaine.
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.
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.
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.
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.
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
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