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Bupivacaine for Pelvic Organ Prolapse

Phase 4

Recruiting

Led By James R Stewart

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing pelvic organ prolapse repair with peritoneal access

Age >= 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours

Awards & highlights

Study Summary

This trial will assess if intraperitoneal Bupivacaine helps reduce post-surgery pain in patients having pelvic organ prolapse repair.

Who is the study for?

This trial is for adults over 18 who are having surgery to fix pelvic organ prolapse and can text message post-surgery. It's not for those allergic to Bupivacaine, with seizure disorders, certain heart conditions, severe liver disease, high bilirubin levels, G6PD deficiency, under 100 lbs in weight or using opiates regularly.Check my eligibility

What is being tested?

The study tests if injecting a painkiller called Bupivacaine into the belly area during surgery helps reduce pain and need for opioids after fixing pelvic organ prolapse. Patients will either get this drug or a saltwater placebo.See study design

What are the potential side effects?

Bupivacaine may cause side effects like numbness around the injection site, weakness, nausea or vomiting. In rare cases it could affect the heart rhythm or cause seizures if it enters the bloodstream.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having surgery to fix pelvic organ prolapse with access through the peritoneum.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain score at 4 hours

Secondary outcome measures

Hospital length of stay

Pain score at 8, 12, 24 hours

Time to first narcotic

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Intraperitoneal bupivacaineActive Control1 Intervention

30 mL of bupivacaine without epinephrine 0.25%

Group II: placeboPlacebo Group1 Intervention

Saline

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

981,672 Total Patients Enrolled

1 Trials studying Pelvic Organ Prolapse

202 Patients Enrolled for Pelvic Organ Prolapse

James R StewartPrincipal InvestigatorIndiana University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of individual is qualified to join this clinical investigation?

"To participate in this trial, those with pelvic organ prolapse must be between 18 and 90 years of age. In total, 90 individuals are predicted to take part in the clinical trial."

Answered by AI

Is enrollment available for adults aged 20 or over in this trial?

"To fulfil the requirements for this clinical trial, participants need to be of legal age (18+) and no older than 90 years."

Answered by AI

What is the current sample size of this research project?

"Yes, according to clinicaltrials.gov, this medical trial is open for enrollment and was initially posted on August 15th 2023. The latest changes were introduced on November 6th 2023 as the study needs 90 participants at a single site."

Answered by AI

Has Intraperitoneal bupivacaine been authorized by the FDA?

"With Phase 4 trials indicating that bupivacaine has been approved, our team at Power assigned a safety rating of 3 to the Intraperitoneal version."

Answered by AI

Are researchers actively seeking participants for this experiment?

"The trial, which was initially made available to the public on August 15th 2023, is currently enrolling participants according to clinicaltrials.gov records; the listing for this study has been updated as recently as November 6th 2023."

Answered by AI

Recent research and studies

Obstetrics & GynecologyJournal

Effect of an Enhanced Recovery After Surgery Program on Opioid Use and Patient-reported Outcomes

Meyer, Larissa A., Javier Lasala, Maria D. Iniesta, Alpa M. Nick, Mark F. Munsell, Qiuling Shi, Xin Shelley Wang, Katherine E. Cain, Karen H. Lu, and Pedro T. Ramirez. 2018. “Effect of an Enhanced Recovery After Surgery Program on Opioid Use and Patient-reported Outcomes”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000002735.

clinicaltrials.govStudy

Intraperitoneal Bupivacaine for Pelvic Organ Prolapse

James Ryan Stewart 2023. "Intraperitoneal Bupivacaine for Pelvic Organ Prolapse". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06120530.

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