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

Postoperative Pain Clinical Trial

Official title:

RANDOMIZED CONTROLLED TRIAL COMPARING LIPOSOMAL BUPIVACAINE VERSUS BUPIVACAINE HCL FOR POSTOPERATIVE MANAGEMENT OF FOREFOOT SURGERY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04751344
• Other study ID #: 101719
• Status: Recruiting
• Phase: Phase 4
• Start date: June 16, 2020
• Est. completion date: June 2022

Study information

• Verified date: February 2021
• Source: Lenox Hill Hospital
• Contact: Alexandra Black, DPM
• Phone: 212-570-9300
• Email: alextblack[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bunion
• Forefoot Surgery
• Liposomal Bupivacaine
• Opioid Use
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Liposomal bupivacaine
Prior to procedure, surgeon will administer 15cc of Lidocaine 2% plain. After the procedure is finished, 8cc of liposomal bupivacaine (13.3mg/mL) will be injected around the surgical site.
• Bupivacaine HCl
Prior to procedure, surgeon will administer 15cc of Lidocaine 2% plain. After the procedure is finished, 10cc of bupivacaine HCl (5mg/mL) will be injected around the surgical site.

Locations

Country	Name	City	State
United States	Manhattan Eyes Ears and Throat Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Alexandra Black

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of liposomal bupivacaine on postoperative pain control	VAS scores, which measure the intensity of pain on a scale of 1 to 10, will be collected at 2, 24, 48 and 72 hours post-operatively in order to assess therapeutic effect of local anesthetic medication for postoperative pain control.	The study will last 72 hours after the elective procedure.
Secondary	Effect of liposomal bupivacaine on opioid use	We will quantify opioid use post-operatively by collecting data on total opioid consumption and time to first use of the opioid post-operatively by the patient	The study will last 72 hours after the elective procedure.