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Local Anesthetic
Liposomal Bupivacaine for Postoperative Pain
Phase 4
Recruiting
Led By Scott Chudnoff, MD
Research Sponsored by Maimonides Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Any patient age > 18 years who is having minimally invasive robotic or laparoscopic total hysterectomy for any indication without any anesthetic block.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours after surgery
Awards & highlights
Study Summary
This trial tests if Exparel injection can reduce pain during hysterectomy for benign causes; pain & meds taken at intervals to compare effectiveness.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as discomfort or swelling, possible nerve damage leading to numbness or weakness, allergic reactions to ingredients in Exparel or bupivacaine, nausea, vomiting, headache, fever and backache.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and will have a minimally invasive hysterectomy without anesthetic block.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain reduction after surgery
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exparel and Bupivacaine GroupExperimental Treatment1 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 GroupActive Control1 Intervention
This group will receive 20ml of bupivicaine in the vaginal cuff
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Who is running the clinical trial?
Maimonides Medical CenterLead Sponsor
69 Previous Clinical Trials
15,215 Total Patients Enrolled
3 Trials studying Postoperative Pain
148 Patients Enrolled for Postoperative Pain
Scott Chudnoff, MDPrincipal InvestigatorMMC
1 Previous Clinical Trials
80 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have had serious allergic reactions to certain types of painkillers or anesthesia.I have had hepatitis B or C in the past.I have taken acetaminophen within a day before surgery.I am not allergic or unable to take acetaminophen, NSAIDs, or opioids.I am currently using or have used steroids like Decadron in the past month.I am over 18 and will have a minimally invasive hysterectomy without anesthetic block.I haven't taken opioids, SSRIs, antidepressants, gabapentin, or pregabalin in the last three days.I have been diagnosed with endometriosis.I have been using pain medication regularly for the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Exparel and Bupivacaine Group
- Group 2: Bupivacaine Only Group
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the combination of Exparel and Bupivacaine Group conform to FDA regulations?
"Due to this being a Phase 4 trial – and therefore have an approved treatment - the safety of Exparel and Bupivacaine Group was rated 3 on our scale."
Answered by AI
How many participants is this experiment recruiting?
"Affirmative, the data posted on clinicaltrials.gov corroborates that this research is currently recruiting participants. This trial was first made public on April 10th 2023 and has since been modified; it seeks 80 contenders across 1 medical site."
Answered by AI
Is enrollment into this research still available?
"Affirmative. Clinicaltrials.gov data indicates that this research study, which was initially made public on April 10th 2023, is actively recruiting participants. Eighty patients must be enrolled from one particular medical centre in order for the trial to move forward."
Answered by AI
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