Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-02-21 @ 6:43 PM
Study NCT ID:
NCT06434233
Status:
RECRUITING
Last Update Posted:
2025-11-12
First Post:
2024-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid Use After Laparoscopic Salpingectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D007247', 'term': 'Infertility, Female'}], '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'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-10', 'studyFirstSubmitDate': '2024-05-23', 'studyFirstSubmitQcDate': '2024-05-23', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric post-operative pain score', 'timeFrame': 'post-operative day 1 and post-operative day 7', 'description': 'Patient reported pain on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" using the Likert pain scale from 0 to 10, where 0 is no pain and 10 is severe pain. A higher score indicates a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Satisfaction with post-operative pain relief', 'timeFrame': 'post-operative day 1 and post-operative day 7', 'description': 'As indicated on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" by a binary "yes" or "no" response. "Yes" indicates a favorable outcome and "no" indicates a worse outcome.'}, {'measure': 'Satisfaction with post-operative mobility', 'timeFrame': 'post-operative day 1 and post-operative day 7', 'description': 'As indicated on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" by a binary "yes" or "no" response. "Yes" indicates a favorable outcome and "no" indicates a worse outcome.'}, {'measure': 'Total narcotic consumption at one week post-operative', 'timeFrame': 'post-operative day 7', 'description': 'Number of Oxycodone pills used by each patient by the end of post-operative day 7'}, {'measure': 'Occurrence of defined opioid related side effects (N/V, constipation, dizziness, itchiness)', 'timeFrame': 'post-operative day 1 and post-operative day 7', 'description': 'As indicated on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" by a binary "yes" or "no" response. "No" indicates a favorable outcome and "yes" indicates a worse outcome.'}, {'measure': 'Suboptimal pain control as assessed by the number of patients requesting additional medication or seeking unplanned medical care for a post-surgical pain-related concern', 'timeFrame': 'Within 30 days of surgery', 'description': 'Number of patients who request additional pain medications at the time of post-operative surveys, call provider phone line for additional pain medications, or return to an Emergency Department, clinic/office, etc due to a pain related issue.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use', 'Post-operative Pain', 'Sterility, Female']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate patient-reported post-operative pain scores following minimally invasive tubal sterilization procedures to determine if a multimodal, non-opioid pain control regimen is non-inferior to a pain control regimen including opioids.\n\nThe study team hypothesizes that with extensive counseling on pain management, multimodal medication use, and expectation with non-opioid methods can effectively eliminate the need for opioid prescriptions after laparoscopic salpingectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with a fallopian tube (unilateral and/or bilateral)\n* Age 18 years old and above\n* Undergoing minimally invasive (laparoscopic or robotic) unilateral or bilateral salpingectomy or other tubal sterilization procedure as the primary procedure\n* Benign indications for salpingectomy/tubal sterilization\n* Agreeing to participate\n\nExclusion Criteria:\n\n* Chronic pain syndromes patients including fibromyalgia\n* Patients currently on long-term (i.e. for more than three months) opioid use\n* Conversion to laparotomy\n* Allergy or other contraindication to the prescribed medications such as acetaminophen or oxycodone\n* Salpingectomy that occurs in conjunction with a major Gyn surgery (i.e. hysterectomy, etc)\n* Salpingectomy performed for treatment of ectopic pregnancy\n* Patients with a history of gastritis and/or GI bleeding'}, 'identificationModule': {'nctId': 'NCT06434233', 'briefTitle': 'Opioid Use After Laparoscopic Salpingectomy', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy', 'orgStudyIdInfo': {'id': 'IRB00308549'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1 - Opioid Post-Op Pain Regimen', 'description': 'Patients randomized to Arm 1 will receive the current most commonly prescribed pain control regimen after a minimally invasive tubal sterilization procedure at discharge.\n\nThese medications include:\n\nTylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and Oxycodone 5 mg orally every 4 hours as needed x 12 tablets\n\nAll patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter', 'interventionNames': ['Drug: Acetaminophen', 'Drug: Ibuprofen', 'Drug: Oxycodone']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 - Non-Opioid Post-Op Pain Regimen', 'description': 'Patients randomized to Arm 2 will not receive an opioid prescription after minimally invasive tubal sterilization procedures at discharge. They will receive only Tylenol and Ibuprofen as follows:\n\nTylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and\n\nAll patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter.\n\nParticipants will be informed that if they need additional pain medications, these will not be withheld. Participants in the second arm who require additional pain medications will receive the same amount of oxycodone as in arm 1.', 'interventionNames': ['Drug: Acetaminophen', 'Drug: Ibuprofen']}], 'interventions': [{'name': 'Acetaminophen', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': 'All patients will receive Acetaminophen 500 mg orally every 6 hours scheduled x 30 tablets at post-operative discharge.\n\nAll patients will be instructed to take Acetaminophen around the clock for the first 72 hours and as needed thereafter.', 'armGroupLabels': ['Arm 1 - Opioid Post-Op Pain Regimen', 'Arm 2 - Non-Opioid Post-Op Pain Regimen']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'description': 'All patients will receive Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets at post-operative discharge.\n\nAll patients will be instructed to take Ibuprofen around the clock for the first 72 hours and as needed thereafter.', 'armGroupLabels': ['Arm 1 - Opioid Post-Op Pain Regimen', 'Arm 2 - Non-Opioid Post-Op Pain Regimen']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': 'Patients randomized to Arm 1 will receive Oxycodone 5 mg orally every 4 hours as needed x 12 tablets at post-operative discharge\n\nPatients randomized to Arm 2 will not receive an Oxycodone prescription at post-operative discharge.\n\nHowever, participants will be informed that if they need additional pain medications, these will not be withheld. Participants in the second arm who require additional pain medications will receive the same amount of Oxycodone as in arm 1', 'armGroupLabels': ['Arm 1 - Opioid Post-Op Pain Regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mostafa Borahay, MD', 'role': 'CONTACT', 'email': 'mboraha1@jhmi.edu', 'phone': '443-997-0400'}], 'facility': 'Johns Hopkins Bayview Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Mostafa Borahay, MD', 'role': 'CONTACT', 'email': 'mboraha1@jhmi.edu', 'phone': '4439970400'}, {'name': 'Shannon Osborne, MD', 'role': 'CONTACT', 'email': 'sosbor13@jh.edu', 'phone': '4105502786'}], 'overallOfficials': [{'name': 'Mostafa Borahay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}