Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT07194694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine vs Ketamine as Adjuvants to Bupivacaine in Transversus Abdominus Plane Block in Inguinal Hernioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': "Sampling Method: Simple random sample. Randomization: Computer generated random list. Blinding: The patient, the physician performing the block and the investigator will be blinded as regard tools and patient's group.\n\nConcealment: Randomization list will be concealed from all members off the study, known only by one person which is not included in it."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'At the end of surgery an ipsilateral US guided TAP block (posterior approach) will be given to all the patients by placing linear US probe (high frequency probe 10-12 MHz) connected to a portable US unit (SonoSite, USA) initially in the mid-axillary plane midway between the lower costal margin and the highest point of iliac crest, then it will be moved posteriorly till a scan reveals the transversus abdominis muscle tailing off into the aponeurosis, near the Quadratus lumborum muscle. The injection site is superficial to the aponeurosis near quadratus lumborum. while the patient in supine position with slight lateralization After skin disinfection, a 22-G 50-mm needle with an injection line will be inserted in plane with the probe. Once the tip of the needle is placed in place and after negative suction 5 ml saline 0.9% will be injected to verify the right place, then 20 ml solution will be injected Group D (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/k'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-27', 'studyFirstSubmitDate': '2025-09-19', 'studyFirstSubmitQcDate': '2025-09-19', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Numeric Pain Rating Scale', 'timeFrame': 'Immediately postoperative - 2 hours postoperatively - 4 hours postoperatively - 6 hours postoperatively - 12 hours postoperatively', 'description': 'The Numeric Pain Rating Scale (NPRS) is an effective method for measuring pain intensity. It consists of an 11-point scale where:\n\n0 represents no pain - 10 represents the worst pain imaginable. Patients are asked to select a whole number that best reflects their pain intensity, typically based on their experience over the last 24 hours or an average pain level.'}], 'secondaryOutcomes': [{'measure': 'Change in Mean arterial blood pressure', 'timeFrame': 'Immediately postoperative - 2 hours postoperative - 4 hours postoperative', 'description': 'MAP = Diastolic Blood Pressure + (1/3 \\* Pulse Pressure). It is the average pressure in your arteries throughout one cardiac cycle and will be calculated after measuring the blood pressure of the patients postoperatively.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain Relief']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to compare the efficacy of two types of analgesic adjuvants in two groups of adult patients undergoing surgeries on unilateral inguinal hernia repair. The key questions it is expected to answer are:\n\nTo what extent do dexmedetomidine and ketamine adjuvants, when combined with bupivacaine, offer a longer analgesic period in a Transversus Abdominis Plane (TAP) block?\n\nTo investigate the time to first request pain medications and pain scores, researchers will rely on three groups:\n\nGroup A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1 mcg/kg dexmedetomidine + normal saline.\n\nGroup B (ketamine group): patients will receive 20 ml of solution containing 1 mg/kg bupivacaine + 0.5 mg/kg ketamine + normal saline.\n\nGroup C (Control Group): Patients will receive 20 ml of solution containing 1 mg/kg bupivacaine + normal saline.\n\nParticipants will:\n\nUndergo general anesthesia in their planned hernia repair. Get injected with a TAP block dose of single ultrasound using one of the three study solutions at the completion of the surgery prior to waking.\n\nMeasure their pain at rest and coughing with particular time intervals (0, 2, 4, 6, and 12 hours) after the operation.\n\nTake common rescue analgesic (nalbuphine) on request depending on the degree of pain.', 'detailedDescription': "Preoperative Assessment:\n\nPatients scheduled for inguinal hernioplasty will be assessed preoperatively by evaluation of their medical history, laboratory investigations, and fulfillmentthe above inclusion criteria. The patient's preparation will be done by IV cannulation with an 18G cannula, and infusion of 500 ml of Ringer's solution will be started, and about 20 minutes before anesthesia induction, midazolam (0.05 mg/kg) will be received as a sedative premedication.\n\nIntraoperative Procedures and Assessments:\n\nAfter reaching the operating room, standard monitoring will be applied, which includes electrocardiography (ECG), non-invasive blood pressure, and pulse oximetry for peripheral oxygen saturation (SPO2). After preoxygenation, induction of general anesthesia will be done by IV injection of propofol (2 mg/kg), fentanyl (2 mcg/kg), atracurium (0.5 mg/kg), and inhalational isoflurane 1.2%, followed by endotracheal intubation and controlled mechanical ventilation with tidal volume 7-8 ml/kg, respiratory rate 12/min, and FIO₂ 100%. Then anesthesia will be maintained by inhalational isoflurane, atracurium 0.1 mg/kg every 20 minutes, and intraoperative fluid (Ringer's solution), which was calculated to cover the maintenance, deficit, and 3rd space requirement.\n\nAt the end of surgery an ipsilateral US-guided TAP block will be given to all the patients by placing a linear US probe (high-frequency probe 10-12 MHz) connected to a portable US unit (SonoSite, USA) in the mid-axillary plane midway between the lower costal margin and the highest point of the iliac crest with the patient in a supine position. After skin disinfection, a 22-G needle with an injection line will be inserted in plane with the probe. Once the tip of the needle is placed in the space between the internal oblique abdominal muscle and transversus abdominis muscle, and after negative suction, 5 ml of 0.9% saline will be injected to distend the transversus abdominis plane, then 20 ml of solution will be made.\n\nGroup A (Dexmedetomidine Group): patients received 20 ml solution containing 1 mg/kg bupivacaine + 1 mcg/kg dexmedetomidine + normal saline.\n\nGroup B (Ketamine Group): patients received 20 ml solution containing 1 mg/kg bupivacaine + 0.5 mg/kg ketamine + normal saline.\n\nGroup C (Control Group): Patients received 20 ml of solution containing 1 mg/kg bupivacaine + normal saline. Then discontinuation of inhalational isoflurane and reversal of muscle blockade by a neostigmine 0.05 mg/kg and atropine (0.01-0.02 mg/kg) mixture, and after fulfillment of extubation criteria, extubation was done.\n\nPostoperative analgesic regimen:\n\nOn demand When NRS \\>3: Nalbuphine (0.1 mg/kg) will be given with a maximum amount of 20 mg per dose and 160 mg per day."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing unilateral inguinal hernioplasty of ASA less than or equal II.\n* Age group: 18-60 years old.\n\nExclusion Criteria:\n\n* Patient refusal.\n* known allergy to any of the used drugs\n* ASA III or above\n* Coagulation disorders and thrombocytopenia\n* Body mass index (BMI) \\>30\n* Infection at needle insertion site\n* Patients undergoing bilateral inguinal'}, 'identificationModule': {'nctId': 'NCT07194694', 'acronym': 'DEX\\KET in TAP', 'briefTitle': 'Dexmedetomidine vs Ketamine as Adjuvants to Bupivacaine in Transversus Abdominus Plane Block in Inguinal Hernioplasty', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Dexmedetomidine vs Ketamine as Adjuvants to Bupivacaine in Transversus Abdominus Plane Block in Inguinal Hernioplasty: A Randomized Clincal Controlled Trial', 'orgStudyIdInfo': {'id': 'MD 42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DEX on TAP', 'description': 'Group D (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1mcg/kg dexmedetomidine +normal saline.', 'interventionNames': ['Drug: Dexmedetomidine & Bupivacaine.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KET on TAP', 'description': 'Group B (ketamine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine+0.5 mg/kg ketamine + normal saline.', 'interventionNames': ['Drug: ketamine and bupivacaine injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'TAP', 'description': 'Group C (Control Group): Patients will receive 20 ml solution containing 1 mg/kg bupivacaine + normal saline.', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'Dexmedetomidine & Bupivacaine.', 'type': 'DRUG', 'description': 'Group A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1mcg/kg dexmedetomidine +normal saline.', 'armGroupLabels': ['DEX on TAP']}, {'name': 'ketamine and bupivacaine injection', 'type': 'DRUG', 'description': 'Group K (ketamine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine+0.5 mg/kg ketamine + normal saline.', 'armGroupLabels': ['KET on TAP']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'Group C (Control Group): Patients will receive 20 ml solution containing 1 mg/kg bupivacaine + normal saline.', 'armGroupLabels': ['TAP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Mariam M Fouad', 'role': 'CONTACT', 'email': 'mariam.mikhail@med.asu.edu.eg', 'phone': '+201274651580'}], 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mariam M Fouad', 'role': 'CONTACT', 'email': 'mariam.mikhail@med.asu.edu.eg', 'phone': '+201274651580'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer at Department: Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University.', 'investigatorFullName': 'Mariam Mikhail Fouad Hanna', 'investigatorAffiliation': 'Ain Shams University'}}}}