Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-07
Brief Title:
Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Effect of Quadratus Lumborum QL Block in Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
In the effort to reduce postoperative opioid use there has been increasing interest in developing multimodal pain regimens to better manage postoperative pain while minimizing opioid use and their subsequent side effects that can be detrimental to the healing process Standard of care approaches to better manage postoperative pain include the Enhanced Recovery After Surgery ERAS protocol and the use of peripheral and truncal nerve blocks Truncal nerve blocks are widely used as an additional modality to provide longer lasting postoperative analgesia and have been adopted as part of the standard of care The goal of this clinical trial is to compare the effects of ERAS alone versus the quadratus lumborum QL nerve block on the postoperative pain experience for women with pelvic organ prolapse undergoing robotic assisted sacrocolpopexy Subjects will be randomized to the ERAS protocol or the QL block The main questions the study aims to answer are 1 does the QL block decrease patient reported pain scores postoperatively and 2 does the QL block decrease the amount of opioid pain medications in the immediate postoperative period The primary outcome measure will be median patient reported pain score in the post-anesthesia care unit PACU following surgery
Detailed Description:
The purpose of this study is to compare patient reported postoperative pain scores in women undergoing QL block versus ERAS protocol alone prior to minimally invasive sacrocolpopexy Secondary aims will explore other outcomes that impact patients overall postoperative pain experience
Aim 1 To compare the median postoperative patient reported pain score in PACU between patients undergoing minimally invasive sacrocolpopexy who are randomized to a preoperative QL block and the ERAS alone group
Aim 2 To compare the maximum postoperative patient reported pain score in PACU between patients undergoing minimally invasive sacrocolpopexy who are randomized to a preoperative QL block and the ERAS alone group
Aim 3 To compare the total oral morphine equivalents OME in PACU between patients undergoing minimally invasive sacrocolpopexy who are randomized to a preoperative QL block and the ERAS alone group
Aim 4 To compare the rates of postoperative nausea and vomiting PONV between patients in the QL block and ERAS alone groups undergoing minimally invasive sacrocolpopexy
Aim 5 To compare the rates of overnight admission between patients in the QL block and ERAS alone groups undergoing minimally invasive sacrocolpopexy
Aim 6 To compare the total time in the PACU between patients in the QL block and ERAS alone groups undergoing minimally invasive sacrocolpopexy
Aim 7 To compare the rates of initial active voiding trial failures between patients in the QL block and ERAS alone groups undergoing minimally invasive sacrocolpopexy
Aim 1 To compare the median postoperative patient reported pain score in PACU between patients undergoing minimally invasive sacrocolpopexy who are randomized to a preoperative QL block and the ERAS alone group
Aim 2 To compare the maximum postoperative patient reported pain score in PACU between patients undergoing minimally invasive sacrocolpopexy who are randomized to a preoperative QL block and the ERAS alone group
Aim 3 To compare the total oral morphine equivalents OME in PACU between patients undergoing minimally invasive sacrocolpopexy who are randomized to a preoperative QL block and the ERAS alone group
Aim 4 To compare the rates of postoperative nausea and vomiting PONV between patients in the QL block and ERAS alone groups undergoing minimally invasive sacrocolpopexy
Aim 5 To compare the rates of overnight admission between patients in the QL block and ERAS alone groups undergoing minimally invasive sacrocolpopexy
Aim 6 To compare the total time in the PACU between patients in the QL block and ERAS alone groups undergoing minimally invasive sacrocolpopexy
Aim 7 To compare the rates of initial active voiding trial failures between patients in the QL block and ERAS alone groups undergoing minimally invasive sacrocolpopexy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None