Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-30 @ 2:40 PM
Study NCT ID:
NCT06495632
Status:
RECRUITING
Last Update Posted:
2025-02-13
First Post:
2024-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scheduled or As Needed Pain Regimen?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}], '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': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D009294', 'term': 'Narcotics'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2024-07-02', 'studyFirstSubmitQcDate': '2024-07-02', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of trial', 'timeFrame': '2 weeks', 'description': 'To measure feasibility of the study, the following data will be collected:\n\n1. Number of participants eligible for the study\n2. Number of participants contacted about the study\n3. Number of participants consented\n4. Number of participants being at least 80% adherent to medication protocol\n5. Number of drop-outs in the study and reason for drop out\n6. Number of Adverse Events reported to study personnel. For all non-consented participants, only counts will be included (e.g., 5 participants who refused to consent), no identifying or private information will be collected.'}], 'secondaryOutcomes': [{'measure': 'Estimate of effect size pain control', 'timeFrame': '2 weeks', 'description': 'Daily diary of pain (10 point scale)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgery', 'acute pain', 'post-operative pain'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine feasibility of a randomized controlled trial and estimates of efficacy for pain control of a scheduled pain regimen versus an as needed pain regimen for participants undergoing same day surgery procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any outpatient surgeries performed at Cape Fear Valley Medical Center by Dr. Van Fossen during the duration of the study, including: laparoscopic cholecystectomy, laparoscopic appendectomy, laparoscopic ventral/umbilical/incisional hernia repair, open ventral/umbilical/incisional hernia repair, laparoscopic inguinal hernia repair, open inguinal hernia repair, lumpectomy, sentinel lymph node biopsy, lymph node biopsy, mass excision skin or subcutaneous, diagnostic laparoscopy, laparoscopic lysis of adhesions, pilonidal cyst excision, hemorrhoidectomy, anal fissure/sphincterotomy, anal fistulectomy, rectal exam under anesthesia, wound debridement, and wound closure\n* Outpatients who are medically eligible to receive the standard post surgery medication protocol (the scheduled pain protocol used in this study).\n* Age 18-65\n\nExclusion Criteria:\n\n* Participants with the following conditions will be excluded from our study: fibromyalgia, chronic pain, cancer (except for breast cancer). This is because these participants have pain at baseline and it will be difficult to discern if their pain is from surgery or their chronic condition.\n* Participants on chronic pain medications will also be excluded from our study because it will be difficult to tell if their pain control is related to their established regimen or the one we are implementing.\n* If participants who are not fluent in English, because all study materials are in English.\n* Participants with stage 3 Chronic Kidney Disease or higher will also be excluded from the study as they cannot take ibuprofen (according to National Kidney Foundation), which is included in our pain regimen.'}, 'identificationModule': {'nctId': 'NCT06495632', 'briefTitle': 'Scheduled or As Needed Pain Regimen?', 'organization': {'class': 'OTHER', 'fullName': 'Cape Fear Valley Health System'}, 'officialTitle': 'Scheduled or As Needed Regimen? a Pilot Feasibility Study on Multimodal Pain Control and Post-Operative Pain', 'orgStudyIdInfo': {'id': '1185-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'scheduled pain regimen', 'description': 'This group will receive post-operative pain medications including narcotics for 2-3 days (Oxycodone/Acetaminophen 5mg/325mg, Hydrocodone/Acetaminophen 5mg/325mg, Hydromorphone 2mg, or Tramadol 50mg) every 4 hours and 800 mg Motrin for 10 days every 8 hours on a fixed time/day schedule.', 'interventionNames': ['Drug: Motrin and narcotic']}, {'type': 'EXPERIMENTAL', 'label': 'as needed pain regimen', 'description': 'This group will receive post-operative pain medications including narcotics for 2-3 days (Oxycodone/Acetaminophen 5mg/325mg, Hydrocodone/Acetaminophen 5mg/325mg, Hydromorphone 2mg, or Tramadol 50mg) every 4 hours and 800 mg Motrin for 10 days every 8 hours as needed for moderate to severe pain (4-10 on numeric rating scale).', 'interventionNames': ['Drug: Motrin and narcotic']}], 'interventions': [{'name': 'Motrin and narcotic', 'type': 'DRUG', 'description': 'See described earlier', 'armGroupLabels': ['as needed pain regimen', 'scheduled pain regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28304', 'city': 'Fayetteville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kaitlyn Benson, DO', 'role': 'CONTACT', 'email': 'KBenson@capefearvalley.com', 'phone': '9104853880'}, {'name': 'Kelly Van Fossen, DO', 'role': 'CONTACT', 'phone': '9104853880'}], 'facility': 'Cape Fear Valley Medical Center', 'geoPoint': {'lat': 35.05266, 'lon': -78.87836}}], 'centralContacts': [{'name': 'Kaitlyn Benson, DO', 'role': 'CONTACT', 'email': 'KBenson@capefearvalley.com', 'phone': '9104853880'}], 'overallOfficials': [{'name': 'Kelly Van Fossen, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cape Fear Valley Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cape Fear Valley Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}