Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT07213635
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse
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': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2025-10-02', 'studyFirstSubmitQcDate': '2025-10-02', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative opioid use', 'timeFrame': 'Assessed verbally during a 5 minute phone call on day 1 and 7 following surgery', 'description': 'Mean postoperative opioid use converted to morphine milligram equivalents'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'Assessed verbally prior to discharge from post anesthesia recovery area, and during 5 minute phone call on day 1 and 7 following surgery', 'description': 'Mean numeric visual analog pain score from 0-10 where 0 is "no pain" and 10 is "worst pain you can imagine"'}, {'measure': 'Global Surgical Recovery score', 'timeFrame': 'Assessed verbally during 5 minute phone call on day 1 and 7 following surgery.', 'description': 'Mean Global Surgical Recovery score (from 0-100%) where 0% is not recovered at all and 100% is fully recovered.'}, {'measure': 'Postdischarge Surgical Recovery', 'timeFrame': 'Assessed during completion of 5 minute survey on week 6 postoperative visit.', 'description': 'Mean Postdischarge Surgical Recovery score (from 0-100) where higher scores denote better recovery.'}, {'measure': 'Adverse events', 'timeFrame': 'From day of surgery until week 6 postoperative visit', 'description': 'Number of hospital admission (including on day of surgery) and emergency department presentations as well as additional calls or urgent clinic visits'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['paracervical block', 'vaginal hysterectomy', 'prolapse repair', 'postoperative opioid use', 'postoperative pain scores', 'postoperative recovery'], 'conditions': ['Opioid Use', 'Surgical Recovery', 'Vaginal Hysterectomy', 'Prolapse Pelvic', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The goal of the study to see if giving a numbing medicine around the cervix (called a paracervical block) during vaginal hysterectomy with prolapse repair helps people feel less pain and need fewer strong pain medicines afterward.\n\nThe main question it aims to answer is:\n\n• Does receiving a paracervical block at the time of vaginal hysterectomy with prolapse repair reduce postoperative opioid use?\n\nResearchers will compare opioid use in participants who receive the an injected numbing medicine (bupivacaine with lidocaine) to those that receive a saltwater liquid placebo.\n\nParticipants will:\n\n* Receive either an injection of the numbing medicine (bupivacaine with lidocaine) or saltwater liquid placebo after they are asleep but before any other parts of the surgery are done\n* Record and report pain medications used for 7 days after surgery\n* Report pain scores before discharge from the post anesthesia recovery area on day of surgery as well as 1 and 7 days after surgery\n* Complete a surgical recovery questionnaire during 6 week postoperative visit\n* Complete a one page multiple-choice test on pelvic organ prolapse', 'detailedDescription': 'Secondary outcomes are to:\n\n1. Compare postoperative pain scores in patients undergoing vaginal hysterectomy for prolapse repair who receive an intraoperative paracervical block compared to placebo\n2. Compare surgical recovery times in patients undergoing vaginal hysterectomy for prolapse repair who receive an intraoperative paracervical block compared to placebo.\n3. Examine incidence of adverse events in patients undergoing vaginal hysterectomy for prolapse repair who receive intraoperative paracervical block compared to placebo'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals undergoing vaginal hysterectomy with concomitant prolapse repair procedure\n\nExclusion Criteria:\n\n* Non-English speaking\n* Weight less than 50 kg\n* Allergy to bupivacaine\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT07213635', 'briefTitle': 'Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Effect of Paracervical Block on Postoperative Opioid Use in Vaginal Hysterectomy for Prolapse: a Randomized, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '25-0619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paracervical block', 'description': 'Participants randomized to this experimental arm will receive a paracervical block with 0.5% bupivacaine with epinephrine at the time of vaginal hysterectomy with prolapse repair', 'interventionNames': ['Drug: Bupivacaine-epinephrine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants randomized to this experimental arm will receive a placebo paracervical injection with normal saline at the time of vaginal hysterectomy with prolapse repair', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Bupivacaine-epinephrine', 'type': 'DRUG', 'description': 'Participants randomized to this experimental arm will receive a paracervical block with 10 mL 0.5% bupivacaine with epinephrine before their vaginal hysterectomy and prolapse repair', 'armGroupLabels': ['Paracervical block']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Participants randomized to this experimental arm will receive a placebo paracervical injection with 10 mL 0.5% normal saline before their vaginal hysterectomy and prolapse repair', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bertie Geng, MD', 'role': 'CONTACT', 'email': 'bertie.geng@unchealth.unc.edu', 'phone': '984-974-0496'}, {'name': 'Marcella Willis-Gray, MD', 'role': 'CONTACT', 'email': 'Marcella_Willis-Gray@med.unc.edu'}, {'name': 'Bertie Geng, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}], 'centralContacts': [{'name': 'Bertie Geng, MD', 'role': 'CONTACT', 'email': 'bertie.geng@unchealth.unc.edu', 'phone': '984-974-0496'}, {'name': 'Marcella Willis-Gray, MD', 'role': 'CONTACT', 'email': 'Marcella_Willis-Gray@med.unc.edu'}], 'overallOfficials': [{'name': 'Bertie Geng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}]}, 'ipdSharingStatementModule': {'timeFrame': 'beginning 12 months following publication until 36 months following publication', 'ipdSharing': 'YES', 'description': 'Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.', 'accessCriteria': 'Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}