Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT06153602
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2023-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Nalbuphine as an Adjuvant to Subarachnoid Block on Postoperative Analgesia in TURP Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009266', 'term': 'Nalbuphine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2023-11-23', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS Pain score', 'timeFrame': '12 hour postoperative', 'description': 'Pain score during motion 12 hours postoperatively was assessed using a standard 10 cm linear Visual Analogue Scale, where 0 represents the minimum score and 10 the maximum, with higher scores indicating worse outcomes.'}], 'secondaryOutcomes': [{'measure': 'VAS Pain score', 'timeFrame': '24 hour postoperative', 'description': 'VAS Pain score at rest and motion at immediate, 1, 6, 12, 24 hour postoperatively was assessed using a standard 10 cm linear Visual Analogue Scale, where 0 represents the minimum score and 10 the maximum, with higher scores indicating worse outcomes.'}, {'measure': 'Time to first rescue analgesia', 'timeFrame': '24 hour postoperative', 'description': 'The time from the intrathecal injection to the first analgesic intervention'}, {'measure': 'Total analgesics consumption', 'timeFrame': '24 hour postoperative', 'description': 'Total analgesics consumption in 24 hour postoperative'}, {'measure': 'Nausea and vomiting incidence', 'timeFrame': '24 hour postoperative', 'description': 'Incidence of adverse effect'}, {'measure': 'Pruritus incidence', 'timeFrame': '24 hour postoperative', 'description': 'Incidence of adverse effect'}, {'measure': 'Sedation score(Ramsay sedation scale)', 'timeFrame': '24 hour postoperative', 'description': "Sedation was assessed using the Ramsay Sedation Scale, which grades sedation on a scale from 1 to 6 based on the patient's responsiveness to stimuli, higher scores generally indicate deeper sedation."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthesia, Spinal', 'Pain, Postoperative', 'Nalbuphine'], 'conditions': ['Transurethral Resection of Prostate']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare pain after surgery in patients undergoing Transurethral Resection of Prostate. The main question it aims to answer are: Intrathecal nalbuphine as an adjuvant to local anesthetic will better provide pain relief after TURP surgery.\n\nParticipants will be given a combination of nalbuphine and local anesthetic when getting a spinal block. Researchers will compare control group, given look-alike solution that contains no active drug to see if nalbuphine will better provide pain relief after surgery.', 'detailedDescription': 'This study aims to evaluate the efficacy and side effects of nalbuphine, with the goal of providing anesthesiologists with evidence-based guidance for selecting the most appropriate pharmacological agents for their patients.\n\nParticipants will be given a combination of nalbuphine and local anesthetic when getting a spinal block. Researchers will compare control group, given look-alike solution that contains no active drug to see if nalbuphine will better provide pain relief after surgery.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for Transurethral Resection of Prostate under spinal anesthesia\n* American Society of Anesthesiologists (ASA) physical status I-III\n\nExclusion Criteria:\n\n* Allergy to study medications or hypersensitive to local anesthetics\n* Contraindicated for neuraxial anesthesia\n* Inability to self-report pain\n* Chronic opioid used'}, 'identificationModule': {'nctId': 'NCT06153602', 'briefTitle': 'Effectiveness of Nalbuphine as an Adjuvant to Subarachnoid Block on Postoperative Analgesia in TURP Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Effectiveness of Intrathecal Nalbuphine as an Adjuvant to Subarachnoid Block on Postoperative Analgesia in Patients Undergoing Transurethral Resection of the Prostate', 'orgStudyIdInfo': {'id': '703/66'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nalbuphine group', 'description': '0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + Nalbuphine(10mg/ml) 0.8 mg intrathecal', 'interventionNames': ['Drug: Nalbuphine Hydrochloride 10 MG/ML', 'Drug: Bupivacaine Hydrochloride, Spinal', 'Drug: Nalbuphine Hcl 10Mg/Ml Inj', 'Drug: Acetaminophen 500Mg Tab', 'Drug: Ondansetron 8mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': '0.5% Hyperbaric or Isobaric Spinal Bupivacaine 5-20 mg (1-4 ml) + 0.9% Sodium chloride 0.08 ml intrathecal', 'interventionNames': ['Drug: Sodium Chloride 0.9 % in 5 ML Injection', 'Drug: Bupivacaine Hydrochloride, Spinal', 'Drug: Nalbuphine Hcl 10Mg/Ml Inj', 'Drug: Acetaminophen 500Mg Tab', 'Drug: Ondansetron 8mg']}], 'interventions': [{'name': 'Nalbuphine Hydrochloride 10 MG/ML', 'type': 'DRUG', 'description': 'Nalbuphine(10mg/ml) 0.8 mg intrathecal', 'armGroupLabels': ['Nalbuphine group']}, {'name': 'Sodium Chloride 0.9 % in 5 ML Injection', 'type': 'DRUG', 'description': '0.9% Sodium Chloride 0.08 ml intrathecal', 'armGroupLabels': ['Control group']}, {'name': 'Bupivacaine Hydrochloride, Spinal', 'type': 'DRUG', 'description': '0.5% Hyperbaric or Isobaric Spinal Bupivacaine 1-4 ml intrathecal', 'armGroupLabels': ['Control group', 'Nalbuphine group']}, {'name': 'Nalbuphine Hcl 10Mg/Ml Inj', 'type': 'DRUG', 'description': '4 mg IV prn for postoperative pain score\\>=4 q 6 h', 'armGroupLabels': ['Control group', 'Nalbuphine group']}, {'name': 'Acetaminophen 500Mg Tab', 'type': 'DRUG', 'description': '1 tab oral prn for postoperative pain score 1-3 q 6 h', 'armGroupLabels': ['Control group', 'Nalbuphine group']}, {'name': 'Ondansetron 8mg', 'type': 'DRUG', 'description': '8 mg IV prn for nausea or vomiting q 8 h', 'armGroupLabels': ['Control group', 'Nalbuphine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Pathum Wan', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Anesthesiology, Faculty of Medicine, Chulalongkorn University', 'geoPoint': {'lat': 13.73649, 'lon': 100.5239}}], 'overallOfficials': [{'name': 'Piyatida Pirasut, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}