Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-03-14 @ 8:22 AM
Study NCT ID:
NCT04198233
Status:
UNKNOWN
Last Update Posted:
2020-07-23
First Post:
2019-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Placement of a Diazepam Suppository on Early Postoperative Pain Following Pelvic Reconstructive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003975', 'term': 'Diazepam'}], 'ancestors': [{'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'All surgeons, patients and research staff will be blinded.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2019-12-11', 'studyFirstSubmitQcDate': '2019-12-12', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal/Rectal pain in Visual Analogue Scale (VAS) score', 'timeFrame': 'between 3.5 and 6 hours postoperatively', 'description': 'VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects draw a vertical line on the scale corresponding to their pain level.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '35550374', 'type': 'DERIVED', 'citation': 'Aldrich ER, Tam TY, Saylor LM, Crisp CC, Yeung J, Pauls RN. Intrarectal diazepam following pelvic reconstructive surgery: a double-blind, randomized placebo-controlled trial. Am J Obstet Gynecol. 2022 Aug;227(2):302.e1-302.e9. doi: 10.1016/j.ajog.2022.05.009. Epub 2022 May 10.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized double-blinded placebo controlled trial to examine the use of rectal diazepam suppositories after major vaginal pelvic organ prolapse surgery will decrease postoperative pain in the interval between 3.5 and 6 hours postoperative compared to placebo.', 'detailedDescription': 'Hysterectomy is the most common major surgery performed in gynecology. Minimally invasive techniques for hysterectomy including vaginal and laparoscopic routes are preferred over the more invasive abdominal procedures, which are associated with more pain, longer hospital stays, and increased rates of complications.\n\nResearch has continued to provide evidence that same day discharge (SDD) after hysterectomy is safe, cost effective, and well received by patients. Pain is a common concern for patients undergoing major pelvic surgery and pain must be well controlled prior to discharge home.\n\nRectal administrations of medications are an attractive option postoperatively in patients desiring SDD. Rectal analgesia avoids 1st pass metabolism in the liver, leading to increased bioavailability of many medications and fewer side effects such as nausea and vomiting.\n\nThe purpose of the study is to investigate whether perioperative administration of a rectally administered diazepam suppository results in improved pain scores between 3.5 and 6 hours postoperatively in patients undergoing major vaginal pelvic reconstructive surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking, able to understand informed consent and questionnaires\n* Vaginal hysterectomy with vaginal vault suspension by one of the providers in the Division of Urogynecology and Reconstructive Pelvic Surgery at TriHealth, Inc.\n\n * With or without anterior and posterior repairs\n * With or without concomitant procedure for stress urinary incontinence\n * With or without removal of fallopian tubes or ovaries\n\nExclusion Criteria:\n\n* Use of mesh for prolapse repair\n* Robotic, laparoscopic, or open technique used for prolapse repair and/or hysterectomy\n* Concomitant procedure done by an additional surgeon\n* Concomitant anal sphincteroplasty or rectovaginal fistula repair\n* Contraindication to use of Diazepam:\n\n * Allergy to Diazepam or other benzodiazepines\n * Acute narrow-angle glaucoma\n * Untreated open-angle glaucoma\n * Myasthenia gravis\n * Severe respiratory impairment\n * Severe hepatic impairment\n* History of chronic pelvic pain receiving medical care\n* Daily use of medication for pain: NSAID, Tylenol, opioid, gabapentin, and/or amitriptyline\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04198233', 'briefTitle': 'Impact of Placement of a Diazepam Suppository on Early Postoperative Pain Following Pelvic Reconstructive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'Impact of Placement of a Diazepam Suppository Intraoperatively on Early Postoperative Pain Following Pelvic Reconstructive Surgery: a Double-Blind, Randomized Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '19-130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diazepam group', 'description': 'Rectal Diazepam suppository', 'interventionNames': ['Drug: Diazepam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo suppository', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Diazepam', 'type': 'DRUG', 'description': 'Diazepam 10 mg compounded suppository', 'armGroupLabels': ['Diazepam group']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Placebo suppository', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily Aldrich, MD', 'role': 'CONTACT', 'email': 'Emily_Aldrich@trihealth.com'}, {'name': 'Rachedl Pauls, MD', 'role': 'CONTACT', 'email': 'Rachel_Pauls@trihealth.com'}], 'facility': 'Trihealth (Good Samaritan Hospital, Bethesda North Hospital)', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Eunsun Yook, MS', 'role': 'CONTACT', 'email': 'eunsun_yook@trihealth.com', 'phone': '513-463-4300'}, {'name': 'Emily Aldrich, MD', 'role': 'CONTACT', 'email': 'Emily_Aldrich@trihealth.com', 'phone': '513-463-4300'}], 'overallOfficials': [{'name': 'Rachel Pauls, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TriHealth - Cincinnati Urogynecology Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}