Liposomal Bupivacaine Versus Bupivacaine Plain for Operative Pain Management of Forefoot Surgery

Alexandra Black

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain; Bunion; Liposomal Bupivacaine; Opioid Use; Forefoot Surgery

Treatments: Drug: Bupivacaine HCl; Drug: Liposomal bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04751344

101719

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Liposomal Bupivacaine

Experimental group

Description:

The liposomal bupivacaine study arm will receive 8cc (13.3 mg/mL) liposomal bupivacaine via intravenous route at the completion of the procedure.

Treatment:

Drug: Liposomal bupivacaine

Bupivacaine HCl

Active Comparator group

Description:

The Bupivacaine HCl study arm will receive 10cc (5mg/mL) of bupivacaine HCl via intravenous route at the completion of the procedure.

Treatment:

Drug: Bupivacaine HCl