Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05823363
Status:
RECRUITING
Last Update Posted:
2023-04-24
First Post:
2023-04-10
Brief Title:
Vaginal Cuff Infiltration With Liposomal Bupivacaine for Pain Relief A Double Blind Randomized Controlled Trial
Sponsor:
Maimonides Medical Center
Organization:
Maimonides Medical Center
Study Overview
Official Title:
Vaginal Cuff Infiltration With Liposomal Bupivacaine for Pain Relief A Double Blind Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
1intervention arm will receive Exparel mixed with bupivicaine 2control arm will receive bupivicaine only
1 pain score at various intervals
2 pain medication used Treatment patients will receive
1intervention arm will receive Exparel mixed with bupivicaine 2control 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 24 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 centers 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 pelvicsuprapubic 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
Intervention arm 40 will get 10ml of Exparel diluted with 10 ml of bupivacaine around 24 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 centers 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 pelvicsuprapubic 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None