Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:50 PM
Study NCT ID:
NCT07426666
Status:
COMPLETED
Last Update Posted:
2026-02-23
First Post:
2026-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Cuff Bupivacaine Injection for Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single-blind study. Participants were blinded to group allocation. The surgeon and clinical staff were aware of the treatment assignment due to the nature of the intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned in a 1:1 ratio to one of two parallel groups using a sealed-envelope method. The intervention group received bilateral vaginal cuff infiltration with 10 mL of 0.25% bupivacaine after cuff closure, while the control group underwent the same surgical procedure without local anesthetic infiltration. The study was conducted as a single-center, open-label randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-15', 'studyFirstSubmitDate': '2026-02-15', 'studyFirstSubmitQcDate': '2026-02-15', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)', 'timeFrame': '1, 3, 6, 12, and 24 hours postoperatively', 'description': 'Pain intensity was assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores were recorded at predefined postoperative time points to evaluate the effectiveness of vaginal cuff bupivacaine infiltration'}, {'measure': 'Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)', 'timeFrame': '1, 3, 6, 12, and 24 hours postoperatively', 'description': 'Pain intensity was assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores were recorded at predefined postoperative time points to evaluate the effectiveness of vaginal cuff bupivacaine infiltration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaginal Hysterectomy', 'Bupivacaine', 'Analgesia'], 'conditions': ['Postoperative Pain Management']}, 'descriptionModule': {'briefSummary': 'This randomized controlled study evaluates whether injecting bupivacaine into the vaginal cuff during vaginal hysterectomy reduces postoperative pain. Vaginal hysterectomy is commonly performed for benign gynecologic conditions. Although it is associated with less pain compared to abdominal surgery, postoperative discomfort may still affect recovery and patient satisfaction.\n\nIn this study, 48 women undergoing elective vaginal hysterectomy were randomly assigned to two groups. In the intervention group, 0.25% bupivacaine was injected bilaterally into the vaginal cuff after closure. In the control group, no local anesthetic injection was administered. All patients received the same standard postoperative pain management protocol.\n\nPain levels were measured using the Visual Analog Scale (VAS) at 1, 3, 6, 12, and 24 hours after surgery. Additional analgesic consumption and possible complications were also recorded. The study aims to determine whether vaginal cuff bupivacaine infiltration improves early postoperative pain control.', 'detailedDescription': 'This prospective, single-center, randomized controlled trial was conducted to evaluate the effect of bilateral vaginal cuff infiltration with 0.25% bupivacaine on postoperative pain following vaginal hysterectomy performed for benign gynecologic indications.\n\nVaginal hysterectomy, although minimally invasive, may still be associated with significant postoperative discomfort. The uterus and surrounding structures receive innervation from the uterosacral plexus (Lee-Frankenhauser plexus), which plays a role in postoperative pain transmission. Local anesthetic infiltration targeting this anatomical region may reduce nociceptive signaling and improve early postoperative pain control.\n\nA total of 48 women aged 35-75 years scheduled for elective vaginal hysterectomy were randomized using a sealed-envelope method into two parallel groups:\n\nIntervention group (n=24): Bilateral infiltration of 10 mL 0.25% bupivacaine into the lateral aspects of the vaginal cuff following cuff closure.\n\nControl group (n=24): Standard surgical procedure without local anesthetic infiltration.\n\nAll procedures were performed under general anesthesia. Postoperative analgesia was administered according to institutional standard protocol. Pain intensity was assessed using the Visual Analog Scale (VAS) at postoperative 1, 3, 6, 12, and 24 hours.\n\nThe primary outcome was postoperative pain intensity measured by VAS scores. Secondary outcomes included total analgesic consumption within the first 24 hours, intraoperative and postoperative complications, and length of hospital stay.\n\nThe study was completed after enrollment of 40 participants, and outcomes were analyzed to determine the efficacy and safety of vaginal cuff bupivacaine infiltration in reducing early postoperative pain following vaginal hysterectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 35 to 75 years\n\nScheduled for elective vaginal hysterectomy for benign gynecologic indications (e.g., uterine fibroids, adenomyosis, abnormal uterine bleeding, pelvic organ prolapse)\n\nAble to provide written informed consent\n\nExclusion Criteria:\n\nKnown or suspected gynecologic malignancy (endometrial, cervical, or uterine)\n\nAllergy or hypersensitivity to local anesthetics, especially bupivacaine\n\nPrior pelvic radiotherapy or major pelvic surgery resulting in altered anatomy\n\nConditions preventing vaginal cuff injection (e.g., extensive scarring, active infection)\n\nInability to reliably assess pain (e.g., impaired consciousness, dementia, severe psychiatric disorder)\n\nRefusal to sign informed consent'}, 'identificationModule': {'nctId': 'NCT07426666', 'acronym': 'marcaine', 'briefTitle': 'Vaginal Cuff Bupivacaine Injection for Postoperative Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gaziosmanpasa Research and Education Hospital'}, 'officialTitle': 'The Effect of Vaginal Cuff Bupivacaine Injection on Postoperative Pain After Vaginal Hysterectomy', 'orgStudyIdInfo': {'id': 'gopvahmarcaine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bupivacaine Injection Group', 'description': 'Participants in this group underwent standard vaginal hysterectomy. After vaginal cuff closure, bilateral infiltration of 10 mL 0.25% bupivacaine was administered to the lateral aspects of the vaginal cuff. All patients received the standard postoperative analgesia protocol.', 'interventionNames': ['Drug: Bupivacaine %0.25 (isobaric)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in this group underwent standard vaginal hysterectomy without local anesthetic infiltration of the vaginal cuff. All patients received the same standard postoperative analgesia protocol.'}], 'interventions': [{'name': 'Bupivacaine %0.25 (isobaric)', 'type': 'DRUG', 'description': '0.25% bupivacaine (10 mL) was bilaterally infiltrated into the lateral aspects of the vaginal cuff following cuff closure during vaginal hysterectomy.', 'armGroupLabels': ['Bupivacaine Injection Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33400', 'city': 'Istanbul', 'state': 'Outside of the US', 'country': 'Turkey (Türkiye)', 'facility': 'SBÜ Gaziosmanpaşa Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Havva Betül Bacak', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'md', 'investigatorFullName': 'Havva Betül Bacak', 'investigatorAffiliation': 'Gaziosmanpasa Research and Education Hospital'}}}}