Clinical trial NCT06309693: Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy
Official title: Effect of Quadratus Lumborum (QL) Block in Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Post Operative Pain
Keywords: minimally invasive sacrocolpopexy
quadratus lumborum block
postoperative pain
pelvic organ prolapse
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a randomized control trial in which patients undergoing robotic-assisted sacrocolpopexy with concurrent robotic assisted hysterectomy or robotic assisted sacrocolpopexy after previous hysterectomy will be randomized to one of two standard of care approaches for postoperative pain management: the enhanced recovery after surgery (ERAS) protocol and the quadratus lumborum truncal nerve block. Subjects will undergo one of two standard of care approaches to postoperative pain management and be asked about their pain postoperatively.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Women undergoing robotic-assisted sacrocolpopexy with concurrent robotic assisted supracervical or total laparoscopic hysterectomy or robotic assisted sacrocolpopexy after previous hysterectomy
2. Age 18 years old or greater
3. Fluency and literacy in English
4. Capacity to provide consent

Exclusion Criteria:

1. Lack fluency and literacy in English

Primary outcomes:
measure: Median postoperative patient reported pain score in post-anesthesia recovery unit (PACU)
timeFrame: Immediate postoperative period while patient is in the PACU
Secondary outcomes:
measure: Maximum postoperative patient reported pain score in PACU
timeFrame: Immediate postoperative period while patient is in the PACU
measure: Total oral morphine equivalents (OME) required in PACU Total oral morphine equivalents (OME) required in post-anesthesia recovery unit
timeFrame: Immediate postoperative period while patient is in the PACU
measure: Rates of postoperative nausea and vomiting (PONV) in PACU
timeFrame: Immediate postoperative period while patient is in PACU
measure: Rates of overnight admission
timeFrame: Day of surgery
measure: Total time spent in PACU
timeFrame: Immediate postoperative period while patient is in the PACU
measure: Rates of initial active voiding trial failures
timeFrame: Immediate postoperative period while patient is in the post-anesthesia recovery unit
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
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