Liposomal Bupivacaine for Postoperative Pain

Overseen By Amro Elfeky, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Maimonides Medical Center

Must not be taking: Opioids, SSRIs, Tricyclics, others

Disqualifiers: Chronic pain, Hepatitis, Endometriosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal is to find out if Exparel (liposomal bupivacaine) given as an injection decreases pain score if given into the vaginal cuff right before starting the minimally invasive (robotic-assisted or laparoscopic) total hysterectomy in patients scheduled for benign indication? Participants will write down 1. pain score at various intervals 2. pain medication used Treatment patients will receive 1)intervention arm will receive Exparel mixed with bupivicaine 2)control arm will receive bupivicaine only

Research Team

Scott Chudnoff, MD

Principal Investigator

MMC

Eligibility Criteria

This trial is for patients over 18 years old undergoing minimally invasive hysterectomy without prior anesthetic blocks. It excludes those who've recently used opioids, certain antidepressants, or pain medications; have significant medical risks; concurrent painful conditions; history of hepatitis (except A); allergies to specific anesthetics or propofol; recent or planned participation in other drug trials; uncontrolled psychiatric disorders; chronic analgesic use.

Exclusion Criteria

You have an untreated mental health condition that could affect your ability to participate in the study.

I have a painful condition or need surgery that requires painkillers unrelated to my hysterectomy.

Nothing unexpected during surgery made my condition unstable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Exparel mixed with bupivacaine or bupivacaine only injected into the vaginal cuff before minimally invasive hysterectomy

1 day

1 visit (in-person)

Immediate Postoperative Monitoring

Pain severity is assessed preoperatively, at PACU arrival, and at 1 hour postoperatively using a VAS scale

1 day

In-hospital monitoring

Follow-up

Participants are monitored for pain and opioid use at 12, 24, 48, and 72 hours postoperatively through phone conversations

3 days

Remote monitoring

Treatment Details

Interventions

• Bupivacaine
• Exparel with Bupivacaine

Trial Overview The study tests if Exparel (liposomal bupivacaine) reduces pain when injected into the vaginal cuff before a robotic-assisted or laparoscopic total hysterectomy. Participants are randomly assigned to two groups: one receives Exparel with bupivacaine and the other receives only bupivacaine, to compare their postoperative pain scores and medication usage.

Participant Groups

Group I: Exparel and Bupivacaine Group Experimental Treatment 1 Intervention

The participants in this group will receive 10 ml of xxparel and 10 ml of bupivacaine in the vaginal cuff

Group II: Bupivacaine Only Group Active Control 1 Intervention

This group will receive 20ml of bupivicaine in the vaginal cuff

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in European Union as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Who Is Running the Clinical Trial?

Maimonides Medical Center

Lead Sponsor

Trials

72

Recruited

15,400+