Pelvic Organ ProlapseNCT06309693
Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy
A study testing Quadratus Lumborum (QL) Block and Enhanced Recovery After Surgical (ERAS) Protocol in people with Pelvic Organ Prolapse and Post Operative Pain, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Post Operative Pain
- What is being tested?
- Quadratus Lumborum (QL) Block and Enhanced Recovery After Surgical (ERAS) Protocol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2025to 9 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing robotic-assisted sacrocolpopexy with concurrent robotic assisted supracervical or total laparoscopic hysterectomy or robotic assisted sacrocolpopexy after previous hysterectomy
- Age 18 years old or greater
- Fluency and literacy in English
- Capacity to provide consent
Who cannot join
- 1. Lack fluency and literacy in English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Effect of Quadratus Lumborum (QL) Block in Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy
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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse, Post Operative Pain
- Being tested
- Quadratus Lumborum (QL) Block, Enhanced Recovery After Surgical (ERAS) Protocol
- Keywords
- minimally invasive sacrocolpopexy, quadratus lumborum block, postoperative pain, pelvic organ prolapse
- Medical subject headings
- Pelvic Organ Prolapse, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus Lumborum (QL) BlockProcedure or surgery
The standard of care QL block will be performed by the regional anesthesia team according to their standard protocol with a uniform quantity and concentration of analgesic agent. Patients will subsequently be asked about their pain postoperatively and opioid medication administration will be quantified.
Enhanced Recovery After Surgical (ERAS) ProtocolProcedure or surgery
Subjects randomized to the ERAS arm will undergo the standard ERAS protocol of early postoperative ambulation, no bowel preparation, and the use of multimodal pain medications including acetaminophen and non-steroid anti-inflammatory drugs (NSAIDs). Patients will subsequently be asked about their pain postoperatively and opioid medication administration will be quantified.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum Block | Active comparator | The QL block will be performed by the regional anesthesia team according to their standard protocol with a uniform quantity and concentration of analgesic agent (ropivacaine 60cc). Intraoperatively, patients will undergo subcutaneous injections of lidocaine (2cc per port site) at each port site. Preoperatively, patients will only receive acetaminophen and no preoperative narcotics or neuro-modulators will be administered. Intraabdominal pressure intraoperative will be standardized among surgeons (plan for 15mm Hg for port placement, then 12 mm Hg once docked). At the conclusion of each surgery, eligible patients will receive a dose of IV ketorolac. Postoperatively, patients will be prescribed a standard regimen of NSAIDs, acetaminophen and opioids. Patients will be asked to rate their pain according to the numeric pain rating scale immediately postoperatively in the PACU and patient opioid requirements while in the PACU will be reviewed in the chart. Receives: Procedure: Quadratus Lumborum (QL) Block |
| Enhanced Recovery After Surgery (ERAS) Protocol | Active comparator | The ERAS protocol is a multimodal approach to pain control while minimizing opioid medications. Subjects randomized to the ERAS arm will undergo the standard ERAS protocol of early postoperative ambulation, no bowel preparation, and the use of multimodal pain medications including acetaminophen and non-steroid anti-inflammatory drugs (NSAIDs). Intraabdominal pressure intraoperative will be standardized among surgeons (plan for 15mm Hg for port placement, then 12 mm Hg once docked). At the conclusion of each surgery, eligible patients will receive a dose of IV ketorolac. Postoperatively, patients will be prescribed a standard regimen of NSAIDs, acetaminophen and opioids. Patients will be asked to rate their pain according to the numeric pain rating scale immediately postoperatively in the PACU and patient opioid requirements while in the PACU will be reviewed in the chart. Receives: Procedure: Enhanced Recovery After Surgical (ERAS) Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median postoperative patient reported pain score in post-anesthesia recovery unit (PACU)
Patients will be asked to rate their pain according to the numeric pain rating scale (0-10) by the nursing staff postoperatively at regular intervals in the PACU and the median score will be calculated.
Measured: Immediate postoperative period while patient is in the PACU
Secondary outcomes (6)
Maximum postoperative patient reported pain score in PACU
Patients will be asked to rate their pain according to the numeric pain rating scale (0-10) by the nursing staff postoperatively at regular intervals in the PACU and the maximum score will be identified.
Measured: Immediate postoperative period while patient is in the PACU
Total oral morphine equivalents (OME) required in PACU Total oral morphine equivalents (OME) required in post-anesthesia recovery unit
The total quantities of opioid pain medications will be identified on patient chart review and calculated into total OME.
Measured: Immediate postoperative period while patient is in the PACU
Rates of postoperative nausea and vomiting (PONV) in PACU
Rates of PONV will be determine by administration of anti-emetic medication in PACU or documentation of PONV in notes.
Measured: Immediate postoperative period while patient is in PACU
Rates of overnight admission
Chart review will be performed to identify patients admitted postoperatively excluding planned admissions.
Measured: Day of surgery
Total time spent in PACU
The total time spent in PACU will be calculated based on chart review.
Measured: Immediate postoperative period while patient is in the PACU
Rates of initial active voiding trial failures
The rates of initial voiding trial failures will be calculated based on chart review.
Measured: Immediate postoperative period while patient is in the post-anesthesia recovery unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start22 Jan 2025
- Primary completion31 Dec 2025
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katelyn Donaldson, MD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309693
- Sponsor's protocol ID
- IRB-300011310
- Status last verified
- Jan 2026
- First submitted
- 7 Mar 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
PubMed 19020158Mavarez AC, Hendrix JM, Ahmed AA. Transabdominal Plane Block. 2023 Nov 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560527/
PubMed 32809362Dua A, Hendrix JM. Quadratus Lumborum Block. 2026 Jun 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537212/
PubMed 30725897El Hachem L, Small E, Chung P, Moshier EL, Friedman K, Fenske SS, Gretz HF 3rd. Randomized controlled double-blind trial of transversus abdominis plane block versus trocar site infiltration in gynecologic laparoscopy. Am J Obstet Gynecol. 2015 Feb;212(2):182.e1-9. doi: 10.1016/j.ajog.2014.07.049. Epub 2014 Aug 1.
PubMed 25088860Hotujec BT, Spencer RJ, Donnelly MJ, Bruggink SM, Rose SL, Al-Niaimi A, Chappell R, Stewart SL, Kushner DM. Transversus abdominis plane block in robotic gynecologic oncology: a randomized, placebo-controlled trial. Gynecol Oncol. 2015 Mar;136(3):460-5. doi: 10.1016/j.ygyno.2014.11.013. Epub 2014 Nov 20.
PubMed 25462201Zoorob D, Tsolakian I, Shuffle E, Perring P, Maxwell R. Addition of Transversus Abdominis Plane Block to Conventional Pain Regimens in Robotic Sacrocolpopexy Procedures-A Pilot Randomized Controlled Trial (SACROTAP). Urogynecology (Phila). 2023 Feb 1;29(2):139-143. doi: 10.1097/SPV.0000000000001287.
PubMed 36735426Fujimoto H, Irie T, Mihara T, Mizuno Y, Nomura T, Goto T. Effect of posterior quadratus lumborum blockade on the quality of recovery after major gynaecological laparoscopic surgery: A randomized controlled trial. Anaesth Intensive Care. 2019 Mar;47(2):146-151. doi: 10.1177/0310057X19838765. Epub 2019 May 15.
PubMed 31090440Hansen C, Dam M, Nielsen MV, Tanggaard KB, Poulsen TD, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block for total laparoscopic hysterectomy: a double-blind, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2021 Jan;46(1):25-30. doi: 10.1136/rapm-2020-101931. Epub 2020 Oct 20.
PubMed 33082286Jiang W, Wang M, Wang X, Jin S, Zhang M, Zhang L, Zhang Y, Wu Y. Effects of Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block on Postoperative Opioid Consumption in Total Laparoscopic Hysterectomy: A Randomized Controlled Clinical Trial. Pain Ther. 2023 Jun;12(3):811-824. doi: 10.1007/s40122-023-00505-1. Epub 2023 Apr 13.
PubMed 37052813Jadon A, Ahmad A, Sahoo RK, Sinha N, Chakraborty S, Bakshi A. Efficacy of transmuscular quadratus lumborum block in the multimodal regimen for postoperative analgesia after total laparoscopic hysterectomy: A prospective randomised double-blinded study. Indian J Anaesth. 2021 May;65(5):362-368. doi: 10.4103/ija.IJA_1258_20. Epub 2021 May 20.
PubMed 34211193Scheib SA, Thomassee M, Kenner JL. Enhanced Recovery after Surgery in Gynecology: A Review of the Literature. J Minim Invasive Gynecol. 2019 Feb;26(2):327-343. doi: 10.1016/j.jmig.2018.12.010. Epub 2018 Dec 20.
PubMed 30580100
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Quadratus Lumborum (QL) Block in Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy
- ClinicalTrials.gov ID
- NCT06309693
- Acronym / sponsor ID
- IRB-300011310
- Conditions
- Pelvic Organ Prolapse, Post Operative Pain
- Keywords
- minimally invasive sacrocolpopexy, quadratus lumborum block, postoperative pain, pelvic organ prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum Block | Active comparator | Procedure: Quadratus Lumborum (QL) BlockThe QL block will be performed by the regional anesthesia team according to their standard protocol with a uniform quantity and concentration of analgesic agent (ropivacaine 60cc). Intraoperatively, patients will undergo subcutaneous injections of lidocaine (2cc per port site) at each port site. Preoperatively, patients will only receive acetaminophen and no preoperative narcotics or neuro-modulators will be administered. Intraabdominal pressure intraoperative will be standardized among surgeons (plan for 15mm Hg for port placement, then 12 mm Hg once docked). At the conclusion of each surgery, eligible patients will receive a dose of IV ketorolac. Postoperatively, patients will be prescribed a standard regimen of NSAIDs, acetaminophen and opioids. Patients will be asked to rate their pain according to the numeric pain rating scale immediately postoperatively in the PACU and patient opioid requirements while in the PACU will be reviewed in the chart. |
| Enhanced Recovery After Surgery (ERAS) Protocol | Active comparator | Procedure: Enhanced Recovery After Surgical (ERAS) ProtocolThe ERAS protocol is a multimodal approach to pain control while minimizing opioid medications. Subjects randomized to the ERAS arm will undergo the standard ERAS protocol of early postoperative ambulation, no bowel preparation, and the use of multimodal pain medications including acetaminophen and non-steroid anti-inflammatory drugs (NSAIDs). Intraabdominal pressure intraoperative will be standardized among surgeons (plan for 15mm Hg for port placement, then 12 mm Hg once docked). At the conclusion of each surgery, eligible patients will receive a dose of IV ketorolac. Postoperatively, patients will be prescribed a standard regimen of NSAIDs, acetaminophen and opioids. Patients will be asked to rate their pain according to the numeric pain rating scale immediately postoperatively in the PACU and patient opioid requirements while in the PACU will be reviewed in the chart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women undergoing robotic-assisted sacrocolpopexy with concurrent robotic assisted supracervical or total laparoscopic hysterectomy or robotic assisted sacrocolpopexy after previous hysterectomy
- Age 18 years old or greater
- Fluency and literacy in English
- Capacity to provide consent
Key exclusion criteria (1 listed)
- 1. Lack fluency and literacy in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadratus Lumborum (QL) BlockThe standard of care QL block will be performed by the regional anesthesia team according to their standard protocol with a uniform quantity and concentration of analgesic agent. Patients will subsequently be asked about their pain postoperatively and opioid medication administration will be quantified. | Procedure or surgery | Quadratus Lumborum Block |
| Enhanced Recovery After Surgical (ERAS) ProtocolSubjects randomized to the ERAS arm will undergo the standard ERAS protocol of early postoperative ambulation, no bowel preparation, and the use of multimodal pain medications including acetaminophen and non-steroid anti-inflammatory drugs (NSAIDs). Patients will subsequently be asked about their pain postoperatively and opioid medication administration will be quantified. | Procedure or surgery | Enhanced Recovery After Surgery (ERAS) Protocol |
Primary outcome
Median postoperative patient reported pain score in post-anesthesia recovery unit (PACU)
Time frame: Immediate postoperative period while patient is in the PACU
Patients will be asked to rate their pain according to the numeric pain rating scale (0-10) by the nursing staff postoperatively at regular intervals in the PACU and the median score will be calculated.
6 secondary outcomes
Maximum postoperative patient reported pain score in PACU
Time frame: Immediate postoperative period while patient is in the PACU
Total oral morphine equivalents (OME) required in PACU Total oral morphine equivalents (OME) required in post-anesthesia recovery unit
Time frame: Immediate postoperative period while patient is in the PACU
Rates of postoperative nausea and vomiting (PONV) in PACU
Time frame: Immediate postoperative period while patient is in PACU
Rates of overnight admission
Time frame: Day of surgery
Total time spent in PACU
Time frame: Immediate postoperative period while patient is in the PACU
Rates of initial active voiding trial failures
Time frame: Immediate postoperative period while patient is in the post-anesthesia recovery unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Background: PubMed 19020158Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
- Background: PubMed 32809362Mavarez AC, Hendrix JM, Ahmed AA. Transabdominal Plane Block. 2023 Nov 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560527/
- Background: PubMed 30725897Dua A, Hendrix JM. Quadratus Lumborum Block. 2026 Jun 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537212/
- Background: PubMed 25088860El Hachem L, Small E, Chung P, Moshier EL, Friedman K, Fenske SS, Gretz HF 3rd. Randomized controlled double-blind trial of transversus abdominis plane block versus trocar site infiltration in gynecologic laparoscopy. Am J Obstet Gynecol. 2015 Feb;212(2):182.e1-9. doi: 10.1016/j.ajog.2014.07.049. Epub 2014 Aug 1.
- Background: PubMed 25462201Hotujec BT, Spencer RJ, Donnelly MJ, Bruggink SM, Rose SL, Al-Niaimi A, Chappell R, Stewart SL, Kushner DM. Transversus abdominis plane block in robotic gynecologic oncology: a randomized, placebo-controlled trial. Gynecol Oncol. 2015 Mar;136(3):460-5. doi: 10.1016/j.ygyno.2014.11.013. Epub 2014 Nov 20.
- Background: PubMed 36735426Zoorob D, Tsolakian I, Shuffle E, Perring P, Maxwell R. Addition of Transversus Abdominis Plane Block to Conventional Pain Regimens in Robotic Sacrocolpopexy Procedures-A Pilot Randomized Controlled Trial (SACROTAP). Urogynecology (Phila). 2023 Feb 1;29(2):139-143. doi: 10.1097/SPV.0000000000001287.
- Background: PubMed 31090440Fujimoto H, Irie T, Mihara T, Mizuno Y, Nomura T, Goto T. Effect of posterior quadratus lumborum blockade on the quality of recovery after major gynaecological laparoscopic surgery: A randomized controlled trial. Anaesth Intensive Care. 2019 Mar;47(2):146-151. doi: 10.1177/0310057X19838765. Epub 2019 May 15.
- Background: PubMed 33082286Hansen C, Dam M, Nielsen MV, Tanggaard KB, Poulsen TD, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block for total laparoscopic hysterectomy: a double-blind, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2021 Jan;46(1):25-30. doi: 10.1136/rapm-2020-101931. Epub 2020 Oct 20.
- Background: PubMed 37052813Jiang W, Wang M, Wang X, Jin S, Zhang M, Zhang L, Zhang Y, Wu Y. Effects of Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block on Postoperative Opioid Consumption in Total Laparoscopic Hysterectomy: A Randomized Controlled Clinical Trial. Pain Ther. 2023 Jun;12(3):811-824. doi: 10.1007/s40122-023-00505-1. Epub 2023 Apr 13.
- Background: PubMed 34211193Jadon A, Ahmad A, Sahoo RK, Sinha N, Chakraborty S, Bakshi A. Efficacy of transmuscular quadratus lumborum block in the multimodal regimen for postoperative analgesia after total laparoscopic hysterectomy: A prospective randomised double-blinded study. Indian J Anaesth. 2021 May;65(5):362-368. doi: 10.4103/ija.IJA_1258_20. Epub 2021 May 20.
- Background: PubMed 30580100Scheib SA, Thomassee M, Kenner JL. Enhanced Recovery after Surgery in Gynecology: A Review of the Literature. J Minim Invasive Gynecol. 2019 Feb;26(2):327-343. doi: 10.1016/j.jmig.2018.12.010. Epub 2018 Dec 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus Lumborum (QL) Block and Enhanced Recovery After Surgical (ERAS) Protocol in people with Pelvic Organ Prolapse and Post Operative Pain, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median postoperative patient reported pain score in post-anesthesia recovery unit (PACU) (time frame: Immediate postoperative period while patient is in the PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06309693, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.