Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04620720
Status:
UNKNOWN
Last Update Posted:
2020-11-09
First Post:
2020-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Operative Pain in Modified Radical Mastectomy.
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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2020-11-04', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post operative pain score', 'timeFrame': '12 hours post oepratively', 'description': 'Visual analog score for pain from 0 to 10. O means no pain. 1 is least and 10 is most severe pain'}], 'secondaryOutcomes': [{'measure': 'analgesia requirement', 'timeFrame': '12 hours post oepratively', 'description': 'change in analgesic requirement a i either groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'we will assess post operative pain after surgery of modified radical mastectomy at 12 and 24 hours post operatively on arm movement and on rest', 'detailedDescription': 'This Randomised control trial will be conducted at the Department of General Surgery, Dow University Hospital OJHA Campus Karachi over a period of a year. All Females, ages ranged between 20 to 80 years and diagnosed with breast carcinoma stage II on the basis of triple assessment will be recruited in the study. Patients who will refuse to participate in the study, allergic to gabapentin on the basis if history, previous treatment with Gabapentin in the previous 8 weeks, Chronic pain syndrome, Substance abuse, sedatives, hypnotics or antidepressants, analgesic intake within 48 hours before surgery, Diabetes mellitus, Hypertension, and Acute or Chronic Renal Failure on the basis of medical records and Inability to understand VAS pain score will be excluded from the study. The sample size will be calculated by the Open Epi calculator. The mean pain score difference at rest between two groups was taken as 0.7 (Placebo: mean ± SD = 2.9 ± 1.2 and Gabapentin: mean ± SD = 2.2 ± 1.3.5 With 80% power, and 95% confidence level, the total sample size came out to be 102, 51 patients in each group. Consecutive sampling was used to achieve the desired sample. Patients fulfilling inclusion criteria were randomly enrolled in either of the 2 groups by sealed opaque envelop method bearing cards, which will be picked by the staff nurses. The intervention group was labeled as group A and the control group as group B. Patients in the intervention group received a single dose of 1200 mg of gabapentin 2hours before surgery. All procedures were performed under general anesthesia. Postoperative analgesic injection ketorolac 30 mg thrice a day and injection paracetamol 1 gram intravenous thrice a day was advised. Patients were assessed at 12 and 24 h post-operatively for pain scores at rest and arm mobilization using VAS pain score, a number of times rescue analgesia when VAS score \\> 3 by residents of surgery blinded to the study. Those patients, who experience pain (pain score \\> 3) in spite of routine analgesics received injection ketorolac 30 mg once, pain score between 3 to 6 received injection Kinz, pain score \\> 7 will be given both analgesics single times, pain score \\>8 will receive intravenous maximum thrice in 24 hours. Patients with pain score 0-2 will not be given any additional analgesic All patients will receive antiemetic in Metoclopramide 10 mg I.V in case of nausea and vomiting. All demographics and outcome variables will be entered in the proforma. The outcome variables of the study were age, pain score (VAS), and analgesic requirement.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Females, age ranged between 20 to 80 years and diagnosed with breast carcinoma stage II on the basis of triple assessment will be recruited in the study\n\nExclusion Criteria:\n\n* Patients who will refuse to participate in the study, allergic to gabapentin on the basis if history, previous treatment with Gabapentin in previous 8 weeks , Chronic pain syndrome, Substance abuse, sedatives, hypnotics or antidepressants ,analgesic intake within 48 hours before surgery, Diabetes mellitus, Hypertension and Acute or Chronic Renal Failure on the basis of medical records'}, 'identificationModule': {'nctId': 'NCT04620720', 'briefTitle': 'Post Operative Pain in Modified Radical Mastectomy.', 'organization': {'class': 'OTHER', 'fullName': 'Combined Military Hospital, Pakistan'}, 'officialTitle': 'Post Operative Pain in Modified Radical Mastectomy.', 'orgStudyIdInfo': {'id': 'DUHSKK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'routuine analgesics wil be given'}, {'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'patient will receive cap gabapentin 1200 mg 2 hours before surgery', 'interventionNames': ['Drug: capule gabapentin']}], 'interventions': [{'name': 'capule gabapentin', 'type': 'DRUG', 'description': 'neuropathic analgesic', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00921', 'city': 'Karachi', 'state': 'Select A State Or Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Anum Arif, MBBS FCPS', 'role': 'CONTACT', 'email': 'dranumarif@yahoo.com', 'phone': '03422398424'}, {'name': 'ammad asim, MBBS FCPS', 'role': 'CONTACT', 'email': 'AMMADASIM@GMAIL.COM', 'phone': '+923422398424'}], 'facility': 'Anum', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'Anum Arif, MBBS FCPS', 'role': 'CONTACT', 'email': 'dranumarif@yahoo.com', 'phone': '+923422398424'}, {'name': 'Ammad Asim, MBBS FCPS', 'role': 'CONTACT', 'email': 'ammadasim@gmail.com', 'phone': '+923422398424'}], 'overallOfficials': [{'name': 'Anum Arif, MBBS FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Combined military hospital lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Combined Military Hospital, Pakistan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Anum Arif', 'investigatorFullName': 'Dr Anum Arif', 'investigatorAffiliation': 'Combined Military Hospital, Pakistan'}}}}