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Bupivacaine liposomal group for Pelvic Organ Prolapse

N/A
Waitlist Available
Led By Katie Propst, MD
Research Sponsored by Hartford Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 7, 14, 28 days post-operative
Awards & highlights

Study Summary

During surgery for pelvic organ prolapse, it is common for the surgeon to inject fluid into the vaginal tissues to help with tissue dissection. It is common that anesthetic medication is mixed into this fluid to help with pain control after surgery. Usually the pain medication injected is short-acting. In this study the investigators plan to compare the usual short-acting injected pain medication with a long-acting injected pain medication to evaluate whether this improves pain control after surgery. One type surgical procedure for prolapse will be evaluated. The procedure is sacrospinous ligament fixation. This is suspension of the vagina to treat pelvic organ prolapse. Study participants will be randomized to one of two study groups: Lidocaine group (short-acting medication). Liposomal bupivacaine group (long-acting medication) Information will be collected on study participants, including: demographics, procedure data, and post-operative information. The primary outcome of this study is determine if use of long-acting injected local anesthesia at the time of sacrospinous ligament fixation leads to less post-operative pain compared to short-acting local anesthesia. Secondary outcomes include: post-operative opioid medication use return to baseline pain status post-operative time to first bowel movement post-operative antiemetic use (nausea medication) results of voiding trial after surgery patient satisfaction with pain control

Eligible Conditions
  • Pelvic Organ Prolapse

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 7, 14, 28 days post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 7, 14, 28 days post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual analog pain scale
Secondary outcome measures
Equivalents of morphine used for pain control post-operative while hospitalized
Equivalents of morphine used from the time of hospital discharge to post-operative day 7
HCHAPS pain questionnaire
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bupivacaine liposomal groupExperimental Treatment1 Intervention
1.3% bupivacaine liposomal (20 mL) injected at the sacrospinous ligament 0.5% lidocaine mixed with 1:200,000 epinephrine 50mL for the anterior / posterior colporrhaphy
Group II: Lidocaine groupActive Control1 Intervention
0.5% lidocaine mixed with 1:200,000 epinephrine 70 milliliters (mL) will be used for local injection at the sacrospinous ligament and for anterior / posterior colporrhaphy

Find a Location

Who is running the clinical trial?

Hartford HospitalLead Sponsor
133 Previous Clinical Trials
18,900 Total Patients Enrolled
4 Trials studying Pelvic Organ Prolapse
461 Patients Enrolled for Pelvic Organ Prolapse
American Association of Gynecologic LaparoscopistsOTHER
1 Previous Clinical Trials
183 Total Patients Enrolled
Katie Propst, MDPrincipal InvestigatorHartford Hospital

Frequently Asked Questions

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~4 spots leftby Apr 2025