Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-26 @ 4:13 PM
Study NCT ID:
NCT02918812
Status:
UNKNOWN
Last Update Posted:
2016-09-29
First Post:
2016-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief in HSG in a Tertiary Hospital in Kano
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'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'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2016-09-25', 'studyFirstSubmitQcDate': '2016-09-27', 'lastUpdatePostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Visual Analogue Score', 'timeFrame': 'Preprocedure and procedure time 0', 'description': "A detailed description of the visual analogue scale (VAS) will be given personally to each woman prior to the procedure. The VAS included a 10 cm linear scale on which 0 represents 'no pain' and 10 represents 'worst pain imaginable'. All patients will be asked to grade their perceived lower abdominal pain levels during specified stages of HSG using the VAS as explained to them. The scale will be used at different stages of the procedure: (1) before beginning the procedure; (2) after speculum application but before instrumentation; (3) after the application of the tenaculum and metal cannula and just before the injection of contrast medium; (4) at the end of uterine filling with contrast medium;"}], 'secondaryOutcomes': [{'measure': "patient's satisfaction with pain relief in the two groups using Likert scale", 'timeFrame': 'Time Frame: 30 minutes post procedure and 24 hours post procedure'}, {'measure': 'Change in pain score from pre-procedure to 5 and 30 minutes post procedure', 'timeFrame': '5 minutes and 30 minutes'}, {'measure': 'Change in pain score from pre-procedure to 5 and 24 hours post procedure', 'timeFrame': '5 minutes and 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hysterosalpingography', 'Pain relief', 'Infertility', 'Intracervical block', 'Diclofenac'], 'conditions': ['Female Infertility of Tubal Origin']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Hamilton M. Infertilty. In Edmonds K (Editor). Dewhurst's Textbook of obstetrics and gynecology. 8th edition. John Wiley and sons ltd 2012 567-79."}, {'pmid': '24359050', 'type': 'BACKGROUND', 'citation': 'Hacivelioglu S, Gencer M, Cakir Gungor A, Kosar S, Koc E, Cosar E. Can the addition of a paracervical block to systemic or local analgesics improve the pain perceived by the patient during hysterosalpingography? J Obstet Gynaecol. 2014 Jan;34(1):48-53. doi: 10.3109/01443615.2013.828025.'}, {'pmid': '22926800', 'type': 'BACKGROUND', 'citation': 'Chauhan MB, Lakra P, Jyotsna D, Nanda S, Malhotra V. Pain relief during hysterosalpingography: role of intracervical block. Arch Gynecol Obstet. 2013 Jan;287(1):155-9. doi: 10.1007/s00404-012-2515-z. Epub 2012 Aug 28.'}, {'pmid': '17197592', 'type': 'BACKGROUND', 'citation': 'Robinson RD, Casablanca Y, Pagano KE, Arthur NA, Bates GW, Propst AM. Intracervical block and pain perception during the performance of a hysterosalpingogram: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):89-93. doi: 10.1097/01.AOG.0000247645.52211.41.'}, {'pmid': '17443612', 'type': 'BACKGROUND', 'citation': 'Ahmad G, Duffy J, Watson AJ. Pain relief in hysterosalpingography. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD006106. doi: 10.1002/14651858.CD006106.pub2.'}, {'type': 'BACKGROUND', 'citation': "Sinnatamby CS editor. Last's Anatomy: Regional and Applied. 11th Edition. Edinburgh. Churchill Livingstone; 2006. P 311-6."}, {'pmid': '12414003', 'type': 'BACKGROUND', 'citation': 'Costello MF, Horrowitz S, Steigrad S, Saif N, Bennett M, Ekangaki A. Transcervical intrauterine topical local anesthetic at hysterosalpingography: a prospective, randomized, double-blind, placebo-controlled trial. Fertil Steril. 2002 Nov;78(5):1116-22. doi: 10.1016/s0015-0282(02)03362-9.'}, {'pmid': '16549607', 'type': 'BACKGROUND', 'citation': 'Simpson WL Jr, Beitia LG, Mester J. Hysterosalpingography: a reemerging study. Radiographics. 2006 Mar-Apr;26(2):419-31. doi: 10.1148/rg.262055109.'}]}, 'descriptionModule': {'briefSummary': 'This study compares the effect of intracervical block with 1% lidocaine and intramuscular diclofenac 75mg in decreasing pain perception during hysterosalpingography. Half of participants will receive intracervical block with 1% lidocaine, while the other half will receive intramuscular diclofenac 75mg.', 'detailedDescription': 'Hysterosalpingography (HSG) is a radiographic test to evaluate the contour of the uterine cavity and patency of the fallopian tubes after injection of a radio-opaque dye through the cervix. It is typically performed in the evaluation of infertility or to diagnose uterine anomalies. It is the most common method of tubal evaluation in the developing countries because it is cheap, readily available and requires less expertise. Unfortunately, HSG can cause discomfort or pain for the patient during or after the procedure, and this evokes anxiety and fear for many patients. Up to 72 % of women complain of significant discomfort with this test.\n\nLidocaine is a local anaesthetic which exerts its effect by altering neuronal depolarization by blocking the sodium channels in the cell membrane, thereby preventing transmission of the sensation of pain to the higher neurons. Lidocaine is commonly used for infiltration and for peripheral nerve blocks if an intermediate duration is required.\n\nDiclofenac is a Non-steroidal anti inflammatory drug that reduce nociception which is related to inflammation and inflammatory mediators whether from trauma'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women with infertility who will be undergoing a hysterosalpingography, and must have given consent will be recruited into the study\n\nExclusion Criteria:\n\n* History of any allergies to local anaesthetics, radio-opaque dye, or anti-inflammatory medications\n* All patients with active pelvic inflammatory diseases\n* All patients with chronic pelvic pain\n* Patients with history of cervical surgery\n* Other indications for hysterosalpingography like Ashermans syndrome, congenital uterine anomalies'}, 'identificationModule': {'nctId': 'NCT02918812', 'briefTitle': 'Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief in HSG in a Tertiary Hospital in Kano', 'organization': {'class': 'OTHER', 'fullName': 'Bayero University Kano, Nigeria'}, 'officialTitle': 'The Effect of Intracervical Lidocaine Versus Intramuscular Diclofenac for Pain Relief During Hysterosalpingography Among Infertile Women In A Tertiary Hospital In Kano: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ONGDaneji1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intracervical lidocaine', 'description': "This group will comprise of patients that will receive the intracervical block. The study group will receive a total of 60 mg (6 mL) of 1% lidocaine to be injected at four points (12, 4, 6, and 8 o'clock) circumferentially into the cervix (1.5 mL at each point) 5 minutes before proceeding with the hysterosalpingogram.", 'interventionNames': ['Drug: Intracervical lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intramuscular Diclofenac', 'description': 'This group will comprise of patients that will receive intramuscular diclofenac potassium 75mg 30 minutes before proceeding with the hysterosalpingogram.', 'interventionNames': ['Drug: Intramuscular Diclofenac']}], 'interventions': [{'name': 'Intracervical lidocaine', 'type': 'DRUG', 'otherNames': ['lignocaine'], 'description': 'Intracervical lidocaine injected at four different points', 'armGroupLabels': ['Intracervical lidocaine']}, {'name': 'Intramuscular Diclofenac', 'type': 'DRUG', 'otherNames': ['Diclofenac sodium', 'Voltaren'], 'description': 'Intramuscular Diclofenac 30 mins before HSG', 'armGroupLabels': ['Intramuscular Diclofenac']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kano', 'state': 'Kano State', 'status': 'RECRUITING', 'country': 'Nigeria', 'contacts': [{'name': 'Sulaiman D Muhammad, MBBS', 'role': 'CONTACT', 'phone': '+2348065305050'}, {'name': 'Sulaiman D Muhammad, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aminu Kano Teaching Hospital', 'geoPoint': {'lat': 12.00012, 'lon': 8.51672}}], 'centralContacts': [{'name': 'Sulaiman D Muhammad, MBBS', 'role': 'CONTACT', 'email': 'smuhddane@yahoo.com', 'phone': '+238065305050'}], 'overallOfficials': [{'name': 'Sulaiman D Muhammad, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aminu Kano Teaching Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayero University Kano, Nigeria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Student', 'investigatorFullName': 'Sulaiman Muhammaad Daneji', 'investigatorAffiliation': 'Bayero University Kano, Nigeria'}}}}