Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-30 @ 12:42 AM
Study NCT ID:
NCT04361695
Status:
UNKNOWN
Last Update Posted:
2020-04-24
First Post:
2020-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preemptive Analgesia for Hemorrhoidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061865', 'term': 'Hemorrhoidectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2022-08-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-23', 'studyFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The frequency of opioid analgesics usage', 'timeFrame': '0-7 days postoperatively', 'description': 'The frequency of opioid administration per day'}], 'secondaryOutcomes': [{'measure': 'Severity of pain', 'timeFrame': '6, 12 and 24 hours after the operation, then 2 times per day up to 7th postoperative day', 'description': 'The severity of the pain syndrome before defecation and after defecation reported by the patient according to Visual Analogue Score (VAS), where 0 - the minimum pain, 10 - the worst pain.'}, {'measure': 'Duration of other analgesics usage', 'timeFrame': '0-7 days postoperatively', 'description': 'The duration in days of systemic and topical analgesics usage'}, {'measure': 'Frequency of other analgesics usage', 'timeFrame': '0-7 days postoperatively', 'description': 'Times per day of systemic and topical analgesics usage'}, {'measure': 'Re-admission rate', 'timeFrame': '30 days postoperatively', 'description': 'The rate of patients who were re-admitted due to refractory pain'}, {'measure': 'Overall quality of life', 'timeFrame': '7th and 30th days postoperatively', 'description': 'Assessed with patient-reported questionnaire Short Form 36 (SF-36). A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability'}, {'measure': 'Returning to work', 'timeFrame': '30 days postoperatively', 'description': 'The period of time in days from the operation to returning to work'}, {'measure': 'The rate of early postoperative complications', 'timeFrame': '0-30 days postoperatively', 'description': 'The rate of complications: bleeding, retention of urine, infectious complications in early postoperative period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemorrhoidectomy']}, 'referencesModule': {'references': [{'pmid': '35761383', 'type': 'DERIVED', 'citation': 'Kazachenko E, Garmanova T, Derinov A, Markaryan D, Lee H, Magbulova S, Tsarkov P. Preemptive analgesia for hemorrhoidectomy: study protocol for a prospective, randomized, double-blind trial. Trials. 2022 Jun 27;23(1):536. doi: 10.1186/s13063-022-06107-0.'}]}, 'descriptionModule': {'briefSummary': 'Preemptive analgesia with the spinal anesthesia allows to decrease pain in hemorrhoidectomy postoperative period. The purpose of this study is to assess the effectiveness of the use of preemptive analgesia with spinal anesthesia to decrease postoperative pain and the amount of used analgesics including opioids.', 'detailedDescription': 'Hemorrhoidectomy, as has being demonstrated to be an effective method of treatment for stage III-IV hemorrhoidal disease. However it is associated with intense postoperative pain that requires the use of multimodal analgesia. Inadequate pain control leads to the prolongation of admission, increasing the consumption of opioid analgesics, patients dissatisfaction with treatment.\n\nAccording to international guidelines of pain management the target level of postoperative pain should be 3-4 or less Visual Analogue Score (VAS) points. The multimodal analgesia including Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), acetaminophen and local anaesthetics are used to reach this aim.\n\nHowever, there are data on effectiveness of preemptive analgesia in anorectal surgery. Preemptive analgesia allows decreasing pain in postoperative period after hemorrhoidectomy.\n\nKetoprophenum is used as an preemptive analgetic agent 1 hour prior to procedure.\n\nThe aim of this prospective, randomized, double-blind study is to assess the effectiveness of the use of preemptive analgesia with Ketoprophenum 10 mg 2 hours before procedure per os with spinal anaesthesia to decrease postoperative pain and the amount of used analgesics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Written informed consent.\n2. Patients over 18 years.\n3. Symptomatic grade III-IV haemorrhoids.\n4. Planned surgery: Milligan-Morgan hemorrhoidectomy\n\nExclusion Criteria:\n\n1. Patient's refusal to participate in the study.\n2. Pregnancy.\n3. Contraindication or technical inability to perform subarachnoid anaesthesia.\n4. Decompensated somatic diseases"}, 'identificationModule': {'nctId': 'NCT04361695', 'briefTitle': 'Preemptive Analgesia for Hemorrhoidectomy', 'organization': {'class': 'OTHER', 'fullName': 'Russian Society of Colorectal Surgeons'}, 'officialTitle': 'Preemptive Analgesia for Hemorrhoidectomy', 'orgStudyIdInfo': {'id': '10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ketoprophenum', 'description': 'A tablet with 10 mg Ketoprophenum is taken per os 2 hours before surgery', 'interventionNames': ['Procedure: Hemorrhoidectomy', 'Drug: Ketoprophenum']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'A tablet containing starch is taken per os 2 hours before surgery', 'interventionNames': ['Procedure: Hemorrhoidectomy', 'Drug: Placebo']}], 'interventions': [{'name': 'Hemorrhoidectomy', 'type': 'PROCEDURE', 'description': 'The patient receives spinal anaesthesia and is placed in lithotomy position. A complex of external and internal haemorrhoid or internal haemorrhoid only is excised with monopolar electrocautery or bipolar electrosurgery device. Haemorrhoid pedicle is tied with absorbable polyfilament suture. One, two or three nodes can be removed per a procedure.', 'armGroupLabels': ['Ketoprophenum', 'Placebo']}, {'name': 'Ketoprophenum', 'type': 'DRUG', 'description': 'Ketoprophenum', 'armGroupLabels': ['Ketoprophenum']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119435', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Tatiana Garmanova, PhD', 'role': 'CONTACT', 'email': 'garmanova@kkmx.ru', 'phone': '+79773429249'}, {'name': 'Daniil Markaryan, PhD', 'role': 'CONTACT', 'email': 'markaryan@kkmx.ru'}], 'facility': 'Clinic of Colorectal and Minimally Invasive Surgery', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Tatiana Garmanova, PhD', 'role': 'CONTACT', 'email': 'garmanova@kkmx.ru', 'phone': '+79773429249'}, {'name': 'Daniil Markaryan, PhD', 'role': 'CONTACT', 'email': 'makaryan@kkmx.ru'}], 'overallOfficials': [{'name': 'Petr Tsarkov, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Russian Society of Colorectal Surgeons'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Russian Society of Colorectal Surgeons', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}