Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-02 @ 5:32 AM
Study NCT ID:
NCT05369468
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2022-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmetomidine With Erector Spinae Plane Block in Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000277', 'term': 'Adjuvants, Pharmaceutic'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010592', 'term': 'Pharmaceutic Aids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'both investigator and outcome assessor do not know in which group is the patient'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-03', 'studyFirstSubmitDate': '2022-04-23', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative morphine consumption', 'timeFrame': 'first 24 hours', 'description': 'the total amount of morphine consumption in the first 24-hour postoperative'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dexmedtomidine-erector spinae block-cholecystectomy'], 'conditions': ['Dexmedtomidine in Erector Spinae Block for Laparscopic Cholecystectomy']}, 'descriptionModule': {'briefSummary': 'Sixty patients scheduled for elective laparoscopic cholecystectomy will be randomly assigned using sealed envelope into two equal groups (30 patients each).\n\nGroup 1: will receive bilateral ESP block with injection of 20 ml of 0.25% Bupivacaine in each site of injection .\n\nGroup 2: will receive bilateral ESP block with injection of 18ml of 0.25% Bupivacaine plus 2ml dexmedetomidine 0.5 ug /kg in each site of injection .', 'detailedDescription': 'This prospective randomized study will be carried out in general surgery Department within 6 months from January 2022 to June 2022 on the 60 patients scheduled for elective laparoscopic cholecystectomy . A written informed consent will be obtained from the patients. Every patient will receive an explanation to the purpose of the study and will have a secret code number and the photos applied only to the part of the body linked to the research to ensure privacy to participants and confidentiality of data.\n\nResearch results will be only used for scientific purposes. Procedures will be approved by both the Institutional and the Regional ethical committees.\n\nThe risk that may occur is minimal, inadequate analgesia and this risk will be overcome by tramadol 50 mg intravenously STAT dose. Any unexpected risk appears during the course of the research will be cleared to the participants and ethical committee on time and proper measures will be taken to overcome or minimize these risks.\n\nThe research end point when reach desired lower pain score postoperative without occurance of any complication as heamodynamic instability.\n\n. Preanesthetic checkup and routine investigations, such as complete blood count test, liver \\&kidney function test and coagulation profile, will be done. Patients will be kept fasting for 8 h.\n\nOn arrival in the operative room, standard monitoring equipment will be attached (electrocardiogram, pulse oximeter, and noninvasive blood pressure) and baseline vital parameters such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), and oxygen saturation (SpO2) will be noted just before induction of anesthesia. Peripheral venous access will be obtained IV crystalloid at rate 10 ml\\\\kg will be infused.\n\nTechnique of ultrasound guided Erector spine plane block:\n\nThe pa¬tient will be placed in sitting position and the ultrasound-guided ESP block was performed bilaterally at the (T7) level. A 23 G spinal needle was inserted with the bevel in cephalo- caudal direction .\n\nSixty patients will be randomly assigned using sealed envelope into two equal groups (30 patients each).\n\nGroup 1: will receive bilateral ESP block with injection of 20 ml of 0.25% Bupivacaine in each site of injection .\n\nGroup 2: will receive bilateral ESP block with injection of 18ml of 0.25% Bupivacaine plus 2ml dexmedetomidine 0.5 ug /kg in each site of injection .\n\nAnesthesia will be induced with injection of propofol 2 mg/kg, and fentanyl 1ug/kg intravenous (I.V) Endotracheal intubation will be facilitated with injection rocuronium bromide 0.9 mg/kg IV. Anesthesia will be maintained with in O2 with sevoflurane 2% to maintained BIS 40-60. Neuromuscular relaxation will be maintained with injection rocuronium top ups of 0.3 mg i.v every hour.\n\nThe lungs will be mechanically ventilated to keep end-tidalCO2 within normal range and residual neuromuscular block will be reversed with injection neostigmine (0.05 mg/kg) and injection atropine (0.01 mg/kg). The patients will be extubated when respiration deemed sufficient. The patients will be transferred to recovery room. In the post anesthesia care unit(PACU), they will be monitored for any evidence of complications or adverse events and discharged when aldert score ≥ 9.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* Patients undergoing elective laparoscopic cholecystectomy\n* aged 18-65 years old\n* ASA physical status I or II.\n\nExclusion Criteria:\n\n* patients who refuse to give written informed consent\n\n * sever respiratory or cardiac disorder\n * coagulopathy\n * local infection at injection site\n * spine or chest wall deformity\n * patients with known allergy to the drugs used'}, 'identificationModule': {'nctId': 'NCT05369468', 'briefTitle': 'Dexmetomidine With Erector Spinae Plane Block in Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Efficacy of Adding Dexmedetomidine to Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '35225/1/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'group 1', 'description': 'Group 1: will receive bilateral ESP block with injection of 20 ml of 0.25% Bupivacaine in each site of injection .', 'interventionNames': ['Drug: Bupivacain only']}, {'type': 'EXPERIMENTAL', 'label': 'group 2', 'description': 'Group 2: will receive bilateral ESP block with injection of 18ml of 0.25% Bupivacaine plus 2ml dexmedetomidine 0.5 ug /kg in each site of injection .', 'interventionNames': ['Drug: dexmedetomidine as adjuvant with bupivacaine']}], 'interventions': [{'name': 'dexmedetomidine as adjuvant with bupivacaine', 'type': 'DRUG', 'description': 'to assess efficacy of adding dexmedetomidine as adjuvant with bupivacaine in ultrasound-guided erector spinae plane block in patient undergoing laporoscopic cholecystectomy. primary outcome was the total amount of morphine consumption in the first 24-hour postoperative, and the secondary outcomes were the time of first rescue analgesia ,pain score, and safety.', 'armGroupLabels': ['group 2']}, {'name': 'Bupivacain only', 'type': 'DRUG', 'description': 'to assess efficacy of bupivacain alone in ultrasound-guided erector spinae plane block in patient undergoing laporoscopic cholecystectomy. primary outcome was the total amount of morphine consumption in the first 24-hour postoperative, and the secondary outcomes were the time of first rescue analgesia ,pain score, and safety.', 'armGroupLabels': ['group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31511', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta University Hospitals', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the result will be shared only after completion of the study and publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Wafaa Madhy Atia Abdelwahed', 'investigatorAffiliation': 'Tanta University'}}}}