Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-27 @ 4:06 PM
Study NCT ID:
NCT06996561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2025-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Impact of Genetic Variations on The Clinical Efficacy of Nalbuphine in Postoperative Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009266', 'term': 'Nalbuphine'}, {'id': 'D059014', 'term': 'High-Throughput Nucleotide Sequencing'}, {'id': 'D000073359', 'term': 'Exome Sequencing'}], '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': 'D017421', 'term': 'Sequence Analysis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000073336', 'term': 'Whole Genome Sequencing'}, {'id': 'D017422', 'term': 'Sequence Analysis, DNA'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 263}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2025-05-21', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score', 'timeFrame': '24 hours postoperatively', 'description': 'Zero is equivalent to no pain and 10 indicates the worst possible pain'}], 'secondaryOutcomes': [{'measure': 'sedation score', 'timeFrame': '24 hours', 'description': 'Sedation will be assessed as 0=no sedation, 1= mild sedation, (eye-opening on verbal commands), 2= moderate sedation (eye-opening on painful stimulus), 3= deep sedation (not waking up on pain).'}, {'measure': 'nausea vomiting score', 'timeFrame': '24 hours postoperatively', 'description': 'o as no nausea and vomiting and 3 as continous vomiting despite giving antiemetic'}, {'measure': 'rescue analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'How much nalbuphine ( opioid) in mg was needed in 24 hours. will signify those not responding to conventional analgesia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['genetic variations', 'nalbuphine', 'opioids', 'polymorphism'], 'conditions': ['Cholecystectomy', 'Hernia, Abdominal', 'Appendectomy', 'Open Colorectal Surgery', 'Laparatomy', 'Postoperative Pain', 'Hysterectomy', 'Cystectomy']}, 'referencesModule': {'references': [{'pmid': '28409480', 'type': 'RESULT', 'citation': 'Agarwal D, Udoji MA, Trescot A. Genetic Testing for Opioid Pain Management: A Primer. Pain Ther. 2017 Jun;6(1):93-105. doi: 10.1007/s40122-017-0069-2. Epub 2017 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to identify the genes as well as their association with Nalbuphine. This will help the investigator to identify opioid vulnerability in Pakistani population in the postoperative patients and will contribute to overcoming the opioid crisis, resulting in better and safer outcomes.\n\nResearch question is:\n\nIs there any association between the underlying genetic variations and the analgesic efficacy of Nalbuphine in postoperative patients? The Research Objectives are\n\n1. To identify the underlying genes in postoperative patients having pain.\n2. To find an association between identified genes and nalbuphine clinical efficacy.\n\nProcedure: After the written informed consent adult men and women will be enrolled in the study. On the day of surgery in the preoperative area, a 5 ml blood sample will be drawn before surgery and will be sent to laboratory for analysis. After routine hemodynamic monitoring in the operative room, general anesthesia will be given including nalbuphine. Standard routine anesthesia monitoring will be done and maintained while monitoring heart rate, ECG, NIBP oxygen saturation, ETCO2 and temperature. Incremental analgesia will be provided whenever needed. After extubation and shifting to recovery room the 2nd sample of blood will be taken and will be sent for analysis. Pain score, nausea vomiting, sedation, requirement of analgesia will be assessed till 24 hours postoperatively.', 'detailedDescription': 'The available data suggests that nalbuphine, tramadol, and morphine exhibit comparable efficacy in treating moderate to severe postoperative pain. However, significant individual variations exist in the analgesic response, which can be attributed to genetic differences. These are the variations that are influenced by a combination of demographic, clinical, and environmental factors with a significant contribution from genetic factors that regulate receptor function and signal transduction. Due to the limited availability of morphine, nalbuphine is an extensively used alternative for managing intraoperative and postoperative pain in many LMICs, particularly in Pakistan. While nalbuphine is clinically effective, there is a gap in understanding the molecular factors that contribute to its efficacy in this genetically distinct population. This highlights the need to investigate the genetic variability and to establish the analgesic efficacy of nalbuphine within Pakistani population. There is no molecular data from the region where the investigator belongs, which highlights the importance of genetic testing to tailor opioid therapy to individual needs, optimizing pain management while minimizing risks such as overdose or inadequate pain relief. By implementing genetics into clinical practice, the investigator can offer more personalized, effective, and safer opioid use, addressing the challenges associated with opioid therapy in diverse patient populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All adult men or women\n2. Age 18 to 70 years\n3. ASA criteria 1,2 and 3\n4. Abdomino-pelvic surgeries (open hernia repair, appendicectomy, open cholecystectomy, laparotomy, hysterectomy, cystectomy) lasting 2-4 hours\n\nExclusion Criteria:\n\n1. Surgical procedure duration lasting more than 4 hours\n2. Patients taking anti fungal fluconazole, anticoagulant (Warfarin or Clopidogrel) SNRI (Amitryptalline), Rifampicin or Buprenorphine,\n3. History of hypersensitivity or allergy to opioids,\n4. Pregnant or breastfeeding mothers,\n5. History of narcotic dependency, addiction, and withdrawal\n6. Patients experiencing any adverse side effects or complications during surgical procedure requiring intensive care admission\n7. Refusing to participate in the study\n8. Surgical procedures utilizing other modes of intraoperative analgesia e.g epidural analgesia or nerve blocks'}, 'identificationModule': {'nctId': 'NCT06996561', 'acronym': 'Nal', 'briefTitle': 'Exploring the Impact of Genetic Variations on The Clinical Efficacy of Nalbuphine in Postoperative Pain Management', 'organization': {'class': 'OTHER', 'fullName': 'Ziauddin University'}, 'officialTitle': 'Exploring the Impact of Genetic Variations on The Clinical Efficacy of Nalbuphine in Postoperative Pain Management', 'orgStudyIdInfo': {'id': 'Nal-Gene123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nalbuphine', 'description': 'Given as intravenously, 0.1-0.2 mg / kg at induction and intermittently', 'interventionNames': ['Drug: Nalbuphine Injection', 'Genetic: Next Generation Sequencing', 'Genetic: whole exome sequencing']}], 'interventions': [{'name': 'Nalbuphine Injection', 'type': 'DRUG', 'description': "Anaesthesia induction will be done with propofol (2 mg/kg) nalbuphine (0.1mg/kg) and atracurium (0.6mg/kg) intravenously. Maintenance of anaesthesia will be achieved with oxygen (O2), nitrous oxide (N2O) in 1:2 ratio and isoflurane (0.8-1%). Intermittent top up of the study drug 1-2 ml boluses will be administered if either the patient's HR or BP increased to 20 % above baseline and when other causes of tachycardia and hypertension are excluded. Timing of analgesia will be recorded. Pain will be assessed for 24 hours postoperatively using verbal rating scale (VRS) with 0 = no pain and 10 = worst pain. Sedation will be assessed as 0=no sedation, 1= mild sedation, (eye-opening on verbal commands), 2= moderate sedation (eye-opening on painful stimulus), 3= deep sedation (not waking up on pain). All patients will be prescribed paracetamol one gram IV six hourly and nalbuphine 1-2 mg IV infusion in the first 24 hours post operatively.", 'armGroupLabels': ['nalbuphine']}, {'name': 'Next Generation Sequencing', 'type': 'GENETIC', 'otherNames': ['NGS', 'whole exome sequencing', "sanger's technique"], 'description': '5ml of blood samples by venipuncture will be obtained from the first 70 patients half an hour before extubation at the time of muscle closure. These blood samples will be processed for DNA analysis. Only the 15 samples where pain persisted despite nalbuphine administration, with a pain score remaining above 4, continuous use of rescue analgesia, or any documented opioid side effects (such as nausea, vomiting, or sedation), or the need for additional analgesia within 24 hours, will be sent for NGS analysis. These samples will undergo whole exome sequencing via NGS, based on patient parameters and pain scores, after being categorized as responders or non-responders to nalbuphine', 'armGroupLabels': ['nalbuphine']}, {'name': 'whole exome sequencing', 'type': 'GENETIC', 'otherNames': ['NGS', 'next generation sequencing'], 'description': 'Only the 15 samples will be sent for NGS based on patient parameters and pain scores after being categorized as responders or non-responders to nalbuphine', 'armGroupLabels': ['nalbuphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '755000', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'contacts': [{'name': 'Asma Abdus Salam, FCPS MCPS MBBS', 'role': 'CONTACT', 'email': 'asma.salam.azhar@gmail.com', 'phone': '03002122264'}, {'name': 'Ambrina Associate Professor, PhD', 'role': 'CONTACT', 'email': 'ambrina.khatoon@zu.edu.pk'}, {'name': 'Asma Abdus Salam, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ambrina Khatoon, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Cyrus Mintz, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ziauddin University', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'Asma Abdus Salam, FCPS, MCPS, MBBS', 'role': 'CONTACT', 'email': 'asma.salam.azhar@gmail.com', 'phone': '+923002122264'}, {'name': 'Zulfiqar Omrani, Director ORIC', 'role': 'CONTACT', 'email': 'director.oric@zu.edu.pk', 'phone': '+9235862937'}], 'overallOfficials': [{'name': 'Talat Mirza, FCPS PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ziauddin University'}]}, 'ipdSharingStatementModule': {'url': 'https://zu.edu.pk/office-of-research-innovation-and-commercialization-oric/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Beginning 3 months and ending 3 years after the publication of results', 'ipdSharing': 'YES', 'description': 'only IPD used in the results publication', 'accessCriteria': 'A data sharing agreement must be signed. Consent and permission should be taken from the PI and officials of Ziauddin for further publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Asma Abdus Salam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr. Asma Abdus Salam', 'investigatorAffiliation': 'Ziauddin University'}}}}