Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT07159334
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"Lignocaine vs GTN Ointment for Postoperative Pain After Hemorrhoidectomy")
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006484', 'term': 'Hemorrhoids'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-02', 'size': 253472, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-17T10:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '"Participants will be randomized into two parallel groups: one receiving topical lignocaine ointment and the other receiving topical glyceryl trinitrate ointment for postoperative pain management after hemorrhoidectomy."'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-08-21', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain score', 'timeFrame': 'Up to 1 month postoperatively.', 'description': 'Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.'}, {'measure': 'Wound Healing Time', 'timeFrame': 'Up to 1 month postoperatively.', 'description': 'Defined as the number of days from the date of surgery until complete wound healing (full epithelialization with no discharge or open area). Shorter duration indicates a better outcome.'}], 'secondaryOutcomes': [{'measure': 'patient Satisfaction Level', 'timeFrame': '6 weeks postoperatively', 'description': 'Overall satisfaction with postoperative care and treatment, assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Higher scores indicate greater satisfaction.'}, {'measure': 'Time to Request of First Analgesic Dose', 'timeFrame': 'Within 24 hours postoperatively', 'description': 'Time (in minutes/hours) from end of surgery to first request for analgesia. Shorter time indicates earlier need for pain control.'}, {'measure': 'Amount of Analgesia Administered in First 24 Hours', 'timeFrame': '0-24 hours postoperatively', 'description': 'Total rescue analgesic dose administered in first 24 hours, recorded in mg (converted to morphine-equivalent dose if applicable). Lower values indicate better pain control.'}, {'measure': 'Incidence of Wound Secretion', 'timeFrame': '1 month postoperatively', 'description': 'Presence of wound secretion (yes/no) as noted on clinical examination.'}, {'measure': 'Incidence of Itching', 'timeFrame': '1 month postoperatively', 'description': 'Patient-reported pruritus at wound site (yes/no)'}, {'measure': 'Incidence of Postoperative Bleeding', 'timeFrame': '1 month postoperatively', 'description': 'Occurrence of wound bleeding postoperatively (yes/no).'}, {'measure': 'Incidence and Severity of Headache', 'timeFrame': '1 month postoperatively', 'description': 'Patient-reported headache severity measured using a Numerical Rating Scale (0 = no headache, 10 = worst imaginable).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemorrhoidectomy', 'Lignocaine ointment', 'Glyceryl Trinitrate ointment', 'Anal pain'], 'conditions': ['Hemorrhoid', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This study is being conducted at the Department of General Surgery, King Edward Medical University, Lahore, Pakistan. The purpose of the trial is to compare the effectiveness of topical Lignocaine ointment versus topical Glyceryl Trinitrate (GTN) ointment in reducing postoperative pain following hemorrhoidectomy.\n\nPatients undergoing hemorrhoidectomy will be randomly assigned to receive either Lignocaine ointment or GTN ointment applied locally after surgery. Pain relief will be assessed using a visual analog scale (VAS) at regular intervals during the postoperative period. The study aims to determine which ointment provides better pain control and improves patient comfort during recovery.', 'detailedDescription': 'This study aims to compare the effectiveness of lignocaine versus 0.2% glyceryl trinitrate (GTN) ointment as postoperative analgesics in patients who have undergone hemorrhoidectomy.\n\nBackground\n\nHemorrhoids are swollen veins in the anal region, commonly treated through Milligan-Morgan hemorrhoidectomy. Postoperative pain is a major concern, affecting mobility and delaying recovery.\n\nVarious treatments have been explored to alleviate post-hemorrhoidectomy pain, including anal dilatation, NSAIDs, opioids, and topical treatments like nifedipine, botulinum toxin, lignocaine, and GTN ointment.\n\nBoth GTN and lignocaine have been shown to reduce pain, but the most effective and safe option is still unclear.\n\nStudy Objective\n\nTo compare the outcomes of lignocaine versus 0.2% GTN ointment in reducing pain and promoting wound healing in post-hemorrhoidectomy patients.\n\nHypothesis\n\nThere is a difference in the pain relief and wound healing outcomes between lignocaine and GTN ointment in hemorrhoidectomy patients.\n\nStudy Design\n\nRandomized clinical trial conducted at the Department of Surgery, Mayo Hospital, Lahore.\n\nDuration: 3-6 months after synopsis approval.\n\nSample Size: 64 patients (32 in each group).\n\nInclusion Criteria: Age 18-60, both genders, Grade III/IV hemorrhoids, ASA grades I \\& II.\n\nExclusion Criteria: Allergies to lignocaine or GTN, pregnancy, concomitant perianal pathology, cardiovascular issues, use of nitrates or calcium channel blockers.\n\nMethods\n\nParticipants will undergo hemorrhoidectomy under spinal anesthesia/saddle block/general anesthesia.\n\nGroup A will receive lignocaine cream, and Group B will receive 0.2% GTN ointment post-operatively (applied 3 times daily).\n\nBoth groups will receive standard postoperative care (sitz baths, stool softeners, and paracetamol for pain).\n\nOutcome Measures:\n\nPain Score using Visual Analogue Scale (VAS) at various time points (6, 12, 24, 48, 72 hours; 7, 14, 21, and 28 days post-surgery).\n\nTime to complete wound healing (measured in days).\n\nLevel of patient satisfaction after 6 weeks using a 5-point Likert scale.\n\nData Analysis\n\nData will be analyzed using SPSS. Descriptive statistics for quantitative variables (e.g., age, pain scores) and qualitative variables (e.g., gender, patient satisfaction).\n\nIndependent t-tests will be used to compare outcomes between groups. A p-value \\< 0.05 will be considered statistically significant.\n\nPatient Follow-Up\n\nPatients will be followed for 6 weeks post-surgery to monitor pain levels, wound healing, and satisfaction.\n\nConclusion\n\nThis trial aims to determine which topical analgesic-lignocaine or GTN ointment-is more effective for postoperative pain management and wound healing in hemorrhoidectomy patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 - 60 years\n* Both genders\n* Grade III and IV hemorrhoids diagnosed on the basis of history and clinical examination by consultant Surgeon.(Grade III Hemorrhoid manually reduced by patient with finger and Grade IV is prolapsed)\n* ASA (American society of Anesthesia) grades I, and II\n\nExclusion Criteria:\n\n* Previously reported allergy or reaction to lignocaine and GTN\n* Pregnancy or lactation\n* Concomitant perianal pathology warranting surgery\n* Cardiovascular disease\n* Patient taking Nitrates or Calcium channel blocker'}, 'identificationModule': {'nctId': 'NCT07159334', 'briefTitle': '"Lignocaine vs GTN Ointment for Postoperative Pain After Hemorrhoidectomy")', 'organization': {'class': 'OTHER', 'fullName': 'King Edward Medical University'}, 'officialTitle': 'Role of Topical Application of Lignocaine Versus 0.2% Glyceryl Trinitrate (GTN) Ointment as a Postoperative Local Analgesic in Hemorrhoidectomy in Terms of Pain Score,Wound Healing Time and Patient Satisfaction Level', 'orgStudyIdInfo': {'id': 'Ahmad Rauf'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1.Lignocaine Ointment Group', 'description': 'Participants will receive topical lignocaine ointment applied to the anal wound post-hemorrhoidectomy for pain control.', 'interventionNames': ['Drug: Lignocaine Ointment', 'Drug: Glyceryl Trinitrate Ointment 0.2%']}, {'type': 'EXPERIMENTAL', 'label': 'Glyceryl Trinitrate Ointment Group', 'description': 'Participants will receive topical 0.2% glyceryl trinitrate ointment applied to the anal wound post-hemorrhoidectomy for pain control.', 'interventionNames': ['Drug: Lignocaine Ointment', 'Drug: Glyceryl Trinitrate Ointment 0.2%']}], 'interventions': [{'name': 'Lignocaine Ointment', 'type': 'DRUG', 'description': 'Applied to the anal wound three time daily after hemorrhoidectomy.', 'armGroupLabels': ['1.Lignocaine Ointment Group', 'Glyceryl Trinitrate Ointment Group']}, {'name': 'Glyceryl Trinitrate Ointment 0.2%', 'type': 'DRUG', 'description': 'Applied to the anal wound three time daily after hemorrhoidectomy.', 'armGroupLabels': ['1.Lignocaine Ointment Group', 'Glyceryl Trinitrate Ointment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Hafiz Ahmad Rauf, Mbbs', 'role': 'CONTACT', 'email': 'ahmadrauf498@gmail.com', 'phone': '+923006023465'}, {'name': 'Hafiz Ahmad Rauf, Mbbs', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'King Edward Medical uUniveristy Mayo Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Hafiz Ahmad Rauf, Mbbs,Fcps', 'role': 'CONTACT', 'email': 'ahmadrauf498@gmail.com', 'phone': '+923006023465'}, {'name': 'KEMU/ Mayo Hospital lahore', 'role': 'CONTACT', 'email': 'info@kemu.edu.pk', 'phone': '+924299214819'}], 'overallOfficials': [{'name': 'Hafiz Ahmad Rauf', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Edward Medical University/Mayo hospital Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Edward Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}