NCT05823363

Vaginal Cuff Infiltration With Liposomal Bupivacaine for Pain Relief: A Double Blind, Randomized Controlled Trial

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Olivia Sher · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The question is whether 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? A reduction in pain after the surgery would result in decrease in opioid usage, fewer opioid-related adverse events, and increased satisfaction in patients. Intervention arm (40) will get 10ml of Exparel diluted with 10 ml of bupivacaine around 2,4, 8 and 10 o' clock in vaginal cuff. Placebo group (40) will receive 20 ml of normal saline in vaginal cuff. All women 35-75 years age range scheduled for Laparoscopic and robotic hysterectomies with Bilateral salpingectomy or bilateral salpingo-oophorectomy will be assessed for eligibility. It is a prospective interventional study that involves use of liposomal bupivacaine and this study will be run in Maimonides medical center's gynecology department . The severity of pain will be assessed preoperatively in the holding area, at the time of PACU arrival, and at 1hour, 12, 24, 48 and 72hours postoperatively using a VAS from 0 to 10 with 10 being the worst pain the patient has ever experienced. The first 3 assessments will be performed in the hospital by the principal investigators and the remaining assessments will happen through a phone conversation with the patient after discharge from hospital. The VAS has been found to be a simple scale. The data will also be collected through chart review and. this data will include age, VAS score reporting by nurses in PACU, BMI, previous abdominal surgery, previous vaginal delivery and parity. Pain inquiries will assess low pelvic/suprapubic area and lower abdominal pain, type of pain (dull, achy, sharp, stabbing, etc.) and radiation of pain to a surrounding area. Other endpoints will include number of patients who required break through (additional) opioid analgesic medications, median time to first break through opioid use, total opioid analgesic requirement. The time, day and number of requests for break-through (additional) analgesia will be noted by gynecologic surgery team (Research assistant) participating in this study. When the patient is home the patient will have a Pain Medication Diary that the investigators will provide for the patient prior to discharge. Patient will be contacted over phone to get the data from her log sheet.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Exparel with Bubivacaine	10ml Exparel mixed with10ml bupivicaine in vaginal cuff
DRUG	Bupivacaine only	20ml of Bubivacaine in the vaginal cugg

Timeline

• Start date: 2024-09-09
• Primary completion: 2024-09-09
• Completion: 2024-09-09
• First posted: 2023-04-21
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study