Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-31 @ 6:49 AM
Study NCT ID:
NCT07072650
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2025-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Adding Dexmedetomidine as an Adjuvant to The Local Anesthetic in Quadratus Lumborum Block in Patient Undergoing Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-06-28', 'studyFirstSubmitQcDate': '2025-07-09', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measured was the postoperative pain level score. The Visual Analog Scale (VAS) was used for assessment, where 0 represented no pain and 10 represented the worst pain.', 'timeFrame': 'The first 24 hours postoperatively'}], 'secondaryOutcomes': [{'measure': 'The time to the first analgesic request (within the first 24 hours postoperatively )', 'timeFrame': 'over the first 24 hours postoperatively'}, {'measure': 'The total analgesic consumption', 'timeFrame': 'Over the first 24 hours postoperatively'}, {'measure': 'Sedation levels', 'timeFrame': 'At 2, 4, 6, 12, and 24 hours postoperatively', 'description': "Sedation levels were also monitored using the Ramsay Sedation Scale which helps assess the patient's level of sedation and consciousness; was used to assess postoperative sedation at 2, 4, 6, 12, and 24 hours postoperatively"}, {'measure': 'Postoperative nausea and vomiting (PONV)', 'timeFrame': 'Within the first 24 hours'}, {'measure': 'Mean Blood Pressure (MBP)', 'timeFrame': 'Perioperative period at intervals of 0, 5, 10, 20, and 30 minutes', 'description': 'Measured in mmHg'}, {'measure': 'Heart Rate (HR)', 'timeFrame': 'Perioperative period at intervals of 0, 5, 10, 20, and 30 minutes', 'description': 'Measured as beats/minute'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'Quadratus lumborum block', 'caesarean section'], 'conditions': ['Dexmedetomidine', 'Quadratus Lumborum Block', 'Postoperative Analgesia', 'Caesarean Section']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the effects of adding Dexmedetomidine to local anesthetic agent (bupivacaine) for quadratus lumborum block (QLB) after spinal anesthesia in patient undergoing elective caesarean section. The main questions it aims to answer are:\n\n1. does adding dexmedetomidine enhance analgesia time?\n2. does adding dexmedetomidine reduce recovery time?\n3. does adding dexmedetomidine lower the need of analgesic medication after surgery? Study include 80 female pregnant non-obese patients scheduled for elective caesarean section.', 'detailedDescription': "Effective postoperative analgesia facilitates a mother's quick recovery, enhances early ambulation, promotes breastfeeding, and reduces the risk of postoperative thromboembolism. The aim of this study was to evaluate the postoperative analgesic efficacy of combining a local anesthetic with dexmedetomidine (DEX) in a quadratus lumborum block (QLB) following a cesarean section (CS). A prospective, randomized, blind, controlled trial included 80 female patients aged 18 - 40 years old who underwent cesarean delivery under spinal anesthesia, were randomly assigned to two equal groups. Group dB received a quadratus lumborum block (QLB) with 20 ml of 0.25% bupivacaine and dexmedetomidine (0.5 μg/kg) on each side, while Group B received QLB with 20 ml of 0.25% bupivacaine alone on each side. The primary outcome measured was total analgesic consumption over 24 hours postoperatively. Secondary outcomes included Visual Analog Scale (VAS) scores, time to first analgesic request, and the incidence of side effects such as sedation, nausea, vomiting, shivering, pruritus, bradycardia, hypotension, and respiratory depression."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age over 18 years' old and less 40 years.\n* With body mass indices (BMI) between 18.5 and 34.9 kg/m²\n* Pregnancy more than 37 weeks with single fetus.\n* Intact membranes.\n* Women with a singleton pregnancy.\n\nExclusion Criteria:\n\n* ASA class III or higher,\n* contraindications to spinal anesthesia,\n* mental or neurological disorders,\n* chronic heart, renal, or liver diseases,\n* emergency surgery,\n* a history of blood coagulation disorders,\n* allergies or contraindications to the study drugs,"}, 'identificationModule': {'nctId': 'NCT07072650', 'briefTitle': 'Impact of Adding Dexmedetomidine as an Adjuvant to The Local Anesthetic in Quadratus Lumborum Block in Patient Undergoing Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Al-Ayen Iraqi University'}, 'officialTitle': 'Impact of Adding Dexmedetomidine as an Adjuvant to The Local Anesthetic in QL3 in Patient Undergoing Caesarean Section', 'orgStudyIdInfo': {'id': '4/2025 in 7/01/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group dB', 'description': 'Adding Dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'NO_INTERVENTION', 'label': 'Group B', 'description': 'Only bupivacaine'}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Studying combining a local anesthetic with dexmedetomidine (DEX) in a quadratus lumborum block (QLB) following a cesarean section (CS) in elective surgery in Bint Al-Huda Hospital.', 'armGroupLabels': ['Group dB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64001', 'city': 'Nasiriyah', 'state': 'Thi Qar', 'country': 'Iraq', 'facility': 'Bint Al-Huda Hospital/ thi qar office directorate', 'geoPoint': {'lat': 31.05799, 'lon': 46.25726}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Majid Fakhir Mutar Alhamaaidah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Scientific committee, Dep. of Anesthesiology, Principal Investigator', 'investigatorFullName': 'Majid Fakhir Mutar Alhamaaidah', 'investigatorAffiliation': 'Al-Ayen Iraqi University'}}}}