Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-06 @ 4:44 PM
Study NCT ID:
NCT07422558
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Nalbuphine Versus Lidocaine for Prevention of Propofol Injection Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073818', 'term': 'Pain, Procedural'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009266', 'term': 'Nalbuphine'}, {'id': 'D008012', 'term': 'Lidocaine'}], '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': 'D000083', 'term': 'Acetanilides'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of propofol- induced injection pain', 'timeFrame': 'During induction of anesthesia (within 1-2 minutes of propofol administration', 'description': 'Presence of injection pain assessed using a four-point pain scale during propofol injection until loss of eyelash reflex. Pain score ≥1 will be considered as presence of injection pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Procedural Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/32748184/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/35436859/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Propofol is a commonly used intravenous anesthetic agent, but its administration is frequently associated with injection pain, causing patient discomfort and agitation. Various pharmacological agents have been used to reduce this pain, including nalbuphine and lidocaine; however, results from previous studies remain conflicting. This randomized clinical trial aims to compare the effectiveness of intravenous nalbuphine versus intravenous lidocaine in reducing the frequency of propofol-induced injection pain in patients undergoing elective general surgery procedures.', 'detailedDescription': 'Propofol-induced injection pain is a common and undesirable adverse effect that can lead to patient distress during induction of anesthesia. Nalbuphine, a kappa-opioid receptor agonist and partial mu-opioid receptor antagonist, and lidocaine, a sodium channel blocker, have both been used to reduce this pain, but evidence regarding their comparative effectiveness remains inconsistent.\n\nThis randomized clinical trial will be conducted in the Department of Anesthesiology, PGMI / Hayatabad Medical Complex, Peshawar. A total of 92 adult patients with ASA physical status I-II, scheduled for elective general surgery under general anesthesia, will be enrolled and randomized into two equal groups. Group A will receive intravenous nalbuphine at a dose of 0.1 mg/kg, while Group B will receive intravenous lidocaine at a dose of 4.5 mg/kg (maximum 300 mg), administered 60 seconds prior to induction with propofol. Injection pain will be assessed by the inducing anesthesiologist using a four-point pai'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-60 years\n\n * Either male or female\n * ASA physical status I or II\n * Scheduled for elective general surgery under general anesthesia using propofol\n\nExclusion Criteria:\n\n* Known hypersensitivity to propofol, nalbuphine, or lidocaine\n\n * Emergency surgery\n * Use of analgesics prior to surgery\n * Pregnant women\n * Lactating women'}, 'identificationModule': {'nctId': 'NCT07422558', 'briefTitle': 'Intravenous Nalbuphine Versus Lidocaine for Prevention of Propofol Injection Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hayatabad Medical Complex'}, 'officialTitle': 'Comprasion of Intravenous Nalbuphine Versus Lidocaine in Reducing Propofol -Induced Injection Pain During General Surgery Procedure', 'orgStudyIdInfo': {'id': 'ANA-PROP-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nalbupine group', 'description': 'Patient recieving intravenous nalbuphine prior to propofol induction', 'interventionNames': ['Drug: Nalbuphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine group', 'description': 'Patient recieving intravenous lidocaine prior to propofol induction', 'interventionNames': ['Drug: Lidocaine']}], 'interventions': [{'name': 'Nalbuphine', 'type': 'DRUG', 'description': 'Intravenous nalbuphine 0.1mg/kg administred 60second prior to induction with propofol', 'armGroupLabels': ['Nalbupine group']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Intravenous lidocaine 4.5mg/kg (maximum 300mg) administred 60sec prior to induction with propofol', 'armGroupLabels': ['Lidocaine group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dr.Arina kore Trainee medical officer, MBBS', 'role': 'CONTACT', 'email': 'Kore2k15@gmail.com', 'phone': '+923446835431'}], 'overallOfficials': [{'name': 'Dr.Arina kore Trainee medical officer, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PGMI/Hayatabad Medical complex(HMC),Peshawar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to patient confidentiality and instituional policies'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hayatabad Medical Complex', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Amina Sultan', 'investigatorAffiliation': 'Hayatabad Medical Complex'}}}}