Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT03099720
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2017-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Local Analgesia to Prevent Pain in Patient Undergoing Removal of the Uterus Through Vaginal Route
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': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2017-03-28', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain score', 'timeFrame': 'At half hour post-operatively', 'description': 'Pain is measured by the patient using the visual analogue score'}, {'measure': 'Pain score', 'timeFrame': 'At one hour post-operatively', 'description': 'Pain is measured by the patient using the visual analogue score'}, {'measure': 'Pain score', 'timeFrame': 'At 4 hours post-operatively', 'description': 'Pain is measured by the patient using the visual analogue score'}, {'measure': 'Pain score', 'timeFrame': 'At 8 hours post-operatively', 'description': 'Pain is measured by the patient using the visual analogue score'}, {'measure': 'Pain score', 'timeFrame': 'At 12 hours post-operatively', 'description': 'Pain is measured by the patient using the visual analogue score'}, {'measure': 'Pain score', 'timeFrame': 'At 24 hours post-operatively', 'description': 'Pain is measured by the patient using the visual analogue score'}], 'primaryOutcomes': [{'measure': 'pain score', 'timeFrame': 'At 2 hours post--operatively.', 'description': 'Pain is measured by the patient using the visual analogue score'}], 'secondaryOutcomes': [{'measure': 'Time in hours to get out of bed after operation', 'timeFrame': 'at 12 hours post--operatively', 'description': 'Time in hours to get out of bed after operation is measured by a nurse responsible for the patient'}, {'measure': 'Hospital stay in days', 'timeFrame': 'Up to 4 weeks post-operatively', 'description': 'Hospital stay in days is measured by a nurse'}, {'measure': 'Total Narcotic dose (Nalbuphine)', 'timeFrame': 'Up to 24 hours post--operatively', 'description': 'Total Narcotic dose (Nalbuphine) is measured by a nurse'}, {'measure': 'Total parenteral NSAID (diclofenac sodium) used in the first 24 hours after surgery', 'timeFrame': 'at 24 hours post-operatively', 'description': 'Total parenteral NSAID (diclofenac sodium) used in the first 24 hours after surgery is measured by a nurse'}, {'measure': 'Proportion of patients with nausea and vomiting in the first 24 hours', 'timeFrame': 'At 24 hours post--operatively', 'description': 'Proportion of patients with nausea and vomiting in the first 24 hours is measured by a nurse'}, {'measure': 'Time spent in the post-anesthesia care unit', 'timeFrame': 'Up to 24 hours post--operatively', 'description': 'Time spent in the post-anesthesia care unit is measured by a nurse'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Following a hysterectomy, women tend to experience high levels of pain, and many require strong pain killers after the procedure. Ropivacaine is a local anaesthetic drug (injectable numbing medication) which works by blocking pain signals. The aim of this study is to find out whether injections of ropivacaine during surgery can help provide effective pain relief after surgery.Women aged between 45 and 70 who are having a vaginal hysterectomy can participate in the trial. Participants are randomly allocated to one of two groups. Those in the first group are given injections of ropivacaine at the site of the wound and in the peritoneum (space in the body that holds the organs in the abdomen) and those in the second group are given injections of a saline fluid in the same places that offers no pain relief before the end of their surgery. Participants in both groups are then regularly asked to rate their pain levels up to 24 hours after surgery. In addition, the pain killers they receive and length of hospital stay are recorded. There is a chance that the participants who receive the ropivacaine will benefit from lower pain levels after surgery. There are no notable risks of participating.', 'detailedDescription': 'At end of the vaginal hysterectomy operation, the gynecologist will inject the uterosacral, cardinal ligaments, adnexal areas and the vaginal edge with 15 ml of either the ropivacaine solution or the placebo fluid in each side, then 20 ml will be instilled inside the peritoneum. Analgesia will be given on request after operation. Visual analogue score of 0 to 100 mm will be used to assess the degree of pain, with 0 indicating no pain and 100 indicating worst pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female\n2. 45 to 70 years old\n3. Scheduled for NDVH (non descent vaginal hysterectomy) for benign indications without need for oophorectomy or vaginal reconstructive surgery\n\nExclusion Criteria:\n\n1. Patient weight less than 50 kg\n2. Allergy to amide local anesthetic\n3. Dementia or mental retardation to a degree which would interfere with data collection\n4. Contraindication to non descent vaginal hysterectomy'}, 'identificationModule': {'nctId': 'NCT03099720', 'briefTitle': 'Local Analgesia to Prevent Pain in Patient Undergoing Removal of the Uterus Through Vaginal Route', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Role of Ropivacaine Postincisional Infiltration With Intraperitoneal Instillation Analgesia in Postoperative Pain Relief in Patients Undergoing Non Descent Vaginal Hysterectomy: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '3777'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'Participants are given ropivacaine (0.5%) at a total dose of 50 ml, 30 ml of which is injected locally and 20 ml into the peritoneum once before the end of operation as pre-emptive analgesia.', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'Participants are given a placebo in the form of fluid injection of saline (0.9%) at total of 50 ml, 30 ml of which is injected locally and 20 ml into the peritoneum once before the end of operation', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'local anesthetic will be given locally at the site of operation to decrease the level of pain after operation', 'armGroupLabels': ['intervention group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo fluid will be given at the site of operation locally', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13518', 'city': 'Banhā', 'state': 'Qalyubia Governorate', 'country': 'Egypt', 'facility': 'Banha University', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'overallOfficials': [{'name': 'Eman Omran, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Eman Omran', 'investigatorAffiliation': 'Cairo University'}}}}