Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT07131527
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Oral Gabapentin Versus Diclofenac Sodium in Post-operative Analgesia Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D010648', 'term': 'Phenylacetates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-08-13', 'studyFirstSubmitQcDate': '2025-08-13', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the effect of preoperative oral Gabapentin versu Diclofenac sodium in adult patient undergoing laparoscopic cholecystectomy', 'timeFrame': '8 hours after operation', 'description': 'postoperative pain by Numerical Rating Scale (0 represents "no pain" while 10 represents "the worst pain)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholecystitis, Chronic']}, 'referencesModule': {'references': [{'pmid': '39340655', 'type': 'BACKGROUND', 'citation': 'Abuahmed M, Rashid R. Day-case laparoscopic cholecystectomy in the management of gallbladder disease: a literature review. Langenbecks Arch Surg. 2024 Sep 28;409(1):292. doi: 10.1007/s00423-024-03479-6.'}, {'pmid': '34904711', 'type': 'BACKGROUND', 'citation': 'Nestor CC, Ng C, Sepulveda P, Irwin MG. Pharmacological and clinical implications of local anaesthetic mixtures: a narrative review. Anaesthesia. 2022 Mar;77(3):339-350. doi: 10.1111/anae.15641. Epub 2021 Dec 14.'}, {'pmid': '36947330', 'type': 'BACKGROUND', 'citation': 'LaForge JM, Urso K, Day JM, Bourgeois CW, Ross MM, Ahmadzadeh S, Shekoohi S, Cornett EM, Kaye AM, Kaye AD. Non-steroidal Anti-inflammatory Drugs: Clinical Implications, Renal Impairment Risks, and AKI. Adv Ther. 2023 May;40(5):2082-2096. doi: 10.1007/s12325-023-02481-6. Epub 2023 Mar 22.'}]}, 'descriptionModule': {'briefSummary': 'this study amis to compare between perioperative oral Gabapentin versus Diclofenac sodium on postoperative analgesia patients undergoing laparoscopic cholecystectomy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge from 20 to 60 years old. Both sexes. American Society of Anesthesiologists (ASA) physical status I- II. Patients undergoing laparoscopic cholecystectomy.\n\nExclusion Criteria:\n\nPatients with hypertension. Pregnant women. Obese patients with BMI \\>35 kg/m2. Alcoholics. Patients With DM Patient refusal'}, 'identificationModule': {'nctId': 'NCT07131527', 'briefTitle': 'Comparison Between Oral Gabapentin Versus Diclofenac Sodium in Post-operative Analgesia Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Comparative Study Between the Efficacy of Pre- Operative Oral Gabapentin Versus Diclofenac Sodium in Post-operative Analgesia in Adult Undergoing Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'Soh-Med--25-7-5MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A will receive oral Gabapentin', 'description': 'Patients included in this group will receive 600 mg of gabapentin 2 h before surgery.', 'interventionNames': ['Drug: Gabapentin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B will receive diclofenac sodium', 'description': 'Patients included in this group will receive 100 mg diclofenac sodium 2 h before surgery.', 'interventionNames': ['Drug: Diclofenac Sodium']}], 'interventions': [{'name': 'Gabapentin', 'type': 'DRUG', 'description': 'oral Gabapentin will be given 2 hours perioperative as postoperative analgesia patients undergoing laparoscopic cholecystectomy', 'armGroupLabels': ['group A will receive oral Gabapentin']}, {'name': 'Diclofenac Sodium', 'type': 'DRUG', 'description': 'oral diclofenac sodium will be given 2 hours perioperative as postoperative analgesia patients undergoing laparoscopic cholecystectomy', 'armGroupLabels': ['group B will receive diclofenac sodium']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, Professor', 'role': 'CONTACT'}], 'facility': 'Sohag university hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Manar Z Ismaiel, Resident', 'role': 'CONTACT', 'email': 'manorzakaria90@gmail.com', 'phone': '01027233046'}, {'name': 'Ahmed E Abdel Rahman, Professor', 'role': 'CONTACT', 'phone': '01118011611'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident , Anesthesia , Surgical Icu , Pain management Faculty of Medicine Sohag university', 'investigatorFullName': 'Manar Zakria Ismail', 'investigatorAffiliation': 'Sohag University'}}}}