Liposomal Bupivacaine Versus Bupivacaine Plain for Operative Pain Management of Forefoot Surgery
Status unconfirmed · Phase 4
Conditions studied: Liposomal Bupivacaine, Postoperative Pain, Forefoot Surgery, Opioid Use, Bunion
In brief
Prospective, randomized, controlled single-blinded trial comparing liposomal bupivacaine with bupivacaine HCl for postoperative management. Upon completion of the forefoot procedure in the operative room the subject will be entered into the randomization system which will specify whether to inject 10cc (5mg/mL) of bupivacaine HCl or 8cc (13.3 mg/mL) liposomal bupivacaine, both considered routine care procedure. Thereafter, postoperative pain will be assessed and measured using a Visual Analog Scale (VAS) scoring scale post-operatively at 2 hours, 24 hours, 48 hours and 72 hours. In addition, the amount of oral morphine equivalents (OME) required postoperatively and time to first use of OME will be measured. Our hypothesis is that patients who received liposomal bupivacaine will have less post-operative pain and require less OMEs.
Key facts
- Study ID
- NCT04751344
- Run by
- Alexandra Black
- People needed
- 100
- Starts
- 2020-06-16
- Expected to finish
- 2022-06-01
- Last updated by the study team
- 2021-02-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, greater than 18 years of age
- ASA Class I or II
- Ability to take oral medication in order to assess the patient's opioid regimen postoperatively
- Forefoot surgery, including bunionectomy +/- digital surgery
- For females of reproductive potential: hCG levels will be determined during the pre-operative period. Females of childbearing age require a hCG level below 5mIU/mL in order to participate in the study. hCG levels above 25 mIU/mL is considered positive for pregnancy and, as a result, the patient will not be considered eligible for inclusion in the study
You may not qualify if…
- Chronic users of opioids, use for greater than 14 days in the last 3 months or nonopioid pain medications for more than 5 times per week
- Prescription for SSRIs, gabapentin, duloxetine within 3 days of surgery
- Systemic glucocorticoids within 1 month of study enrollment
- History of hepatitis
- History of peripheral vascular disease
- History of diabetes mellitus type 1 or 2
- Pregnancy or lactation
- Allergic to opioids
- Known allergic reactions to components of the bupivacaine injectable or other amide anesthetics; the allergen may involve preservative compounds such as methylparaben used in the preparation of amide-type agents are metabolized to PABA
- BMI > 40
Where it is running
- Manhattan Eyes Ears and Throat Hospital — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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