Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-26 @ 1:41 PM
Study NCT ID:
NCT06309693
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2024-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003766', 'term': 'Dental Occlusion'}, {'id': 'D002985', 'term': 'Clinical Protocols'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2024-03-07', 'studyFirstSubmitQcDate': '2024-03-07', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median postoperative patient reported pain score in post-anesthesia recovery unit (PACU)', 'timeFrame': 'Immediate postoperative period while patient is in the PACU', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Maximum postoperative patient reported pain score in PACU', 'timeFrame': 'Immediate postoperative period while patient is in the PACU', 'description': '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.'}, {'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', 'description': 'The total quantities of opioid pain medications will be identified on patient chart review and calculated into total OME.'}, {'measure': 'Rates of postoperative nausea and vomiting (PONV) in PACU', 'timeFrame': 'Immediate postoperative period while patient is in PACU', 'description': 'Rates of PONV will be determine by administration of anti-emetic medication in PACU or documentation of PONV in notes.'}, {'measure': 'Rates of overnight admission', 'timeFrame': 'Day of surgery', 'description': 'Chart review will be performed to identify patients admitted postoperatively excluding planned admissions.'}, {'measure': 'Total time spent in PACU', 'timeFrame': 'Immediate postoperative period while patient is in the PACU', 'description': 'The total time spent in PACU will be calculated based on chart review.'}, {'measure': 'Rates of initial active voiding trial failures', 'timeFrame': 'Immediate postoperative period while patient is in the post-anesthesia recovery unit', 'description': 'The rates of initial voiding trial failures will be calculated based on chart review.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['minimally invasive sacrocolpopexy', 'quadratus lumborum block', 'postoperative pain', 'pelvic organ prolapse'], 'conditions': ['Pelvic Organ Prolapse', 'Post Operative Pain']}, 'referencesModule': {'references': [{'pmid': '19020158', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32809362', 'type': 'BACKGROUND', 'citation': 'Mavarez AC, Hendrix JM, Ahmed AA. Transabdominal Plane Block. 2023 Nov 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560527/'}, {'pmid': '30725897', 'type': 'BACKGROUND', 'citation': 'Dhanjal ST, Tonder S. Quadratus Lumborum Block. 2023 Aug 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537212/'}, {'pmid': '25088860', 'type': 'BACKGROUND', 'citation': 'El 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.'}, {'pmid': '25462201', 'type': 'BACKGROUND', 'citation': 'Hotujec 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.'}, {'pmid': '36735426', 'type': 'BACKGROUND', 'citation': 'Zoorob 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.'}, {'pmid': '31090440', 'type': 'BACKGROUND', 'citation': 'Fujimoto 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.'}, {'pmid': '33082286', 'type': 'BACKGROUND', 'citation': 'Hansen 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.'}, {'pmid': '37052813', 'type': 'BACKGROUND', 'citation': 'Jiang 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.'}, {'pmid': '34211193', 'type': 'BACKGROUND', 'citation': 'Jadon 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.'}, {'pmid': '30580100', 'type': 'BACKGROUND', 'citation': 'Scheib 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nAim #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.\n\nAim #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.\n\nAim #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.\n\nAim #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.\n\nAim #5: To compare the rates of overnight admission between patients in the QL block and ERAS alone groups undergoing minimally invasive sacrocolpopexy.\n\nAim #6: To compare the total time in the PACU between patients in the QL block and ERAS alone groups undergoing minimally invasive sacrocolpopexy.\n\nAim #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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women undergoing robotic-assisted sacrocolpopexy with concurrent robotic assisted supracervical or total laparoscopic hysterectomy or robotic assisted sacrocolpopexy after previous hysterectomy\n2. Age 18 years old or greater\n3. Fluency and literacy in English\n4. Capacity to provide consent\n\nExclusion Criteria:\n\n1\\. Lack fluency and literacy in English'}, 'identificationModule': {'nctId': 'NCT06309693', 'briefTitle': 'Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Effect of Quadratus Lumborum (QL) Block in Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy', 'orgStudyIdInfo': {'id': 'IRB-300011310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Quadratus Lumborum Block', 'description': '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.', 'interventionNames': ['Procedure: Quadratus Lumborum (QL) Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Recovery After Surgery (ERAS) Protocol', 'description': '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.', 'interventionNames': ['Procedure: Enhanced Recovery After Surgical (ERAS) Protocol']}], 'interventions': [{'name': 'Quadratus Lumborum (QL) Block', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Quadratus Lumborum Block']}, {'name': 'Enhanced Recovery After Surgical (ERAS) Protocol', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Enhanced Recovery After Surgery (ERAS) Protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katelyn Donaldson, MD', 'role': 'CONTACT', 'email': 'katelyndonaldson@uabmc.edu', 'phone': '205-996-7372'}, {'name': 'Sunita Patel', 'role': 'CONTACT', 'email': 'sunitapatel@uabmc.edu'}, {'name': 'Katelyn Donaldson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'centralContacts': [{'name': 'Katelyn Donaldson, MD', 'role': 'CONTACT', 'email': 'katelyndonaldson@uabmc.edu', 'phone': '205-996-7372'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow, Division of Urogynecology and Pelvic Reconstructive Surgery', 'investigatorFullName': 'Katelyn Donaldson, MD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}