Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT00372658
Status:
COMPLETED
Last Update Posted:
2006-09-07
First Post:
2006-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intracervical Block Versus Placebo to Assess Pain Control During Hysterosalpingogram
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-12', 'completionDateStruct': {'date': '2004-10'}, 'lastUpdateSubmitDate': '2006-09-06', 'studyFirstSubmitDate': '2006-09-05', 'studyFirstSubmitQcDate': '2006-09-06', 'lastUpdatePostDateStruct': {'date': '2006-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue and qualitative scales to assess study participants pain at 6 different time points during the hysterosalpingogram.'}], 'secondaryOutcomes': [{'measure': 'Anatomical result of the hysterosalpingogram were also collected for a sub-group analysis to evaluate if particular pathology had an effect on pain scores.'}]}, 'conditionsModule': {'keywords': ['hysterosalpingogram', 'intracervical local anesthesia', 'pain perception', 'visual analogue scale'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '17197592', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of 1% lidocaine intracervical block to placebo for pain control during the performance of a hysterosalpingogram (HSG). We hypothesized that an intracervical block would decrease pain during a hysterosalpingogram.', 'detailedDescription': 'The hysterosalpingogram (HSG) is an integral part of the evaluation for anatomic etiologies of female infertility. The majority of women regard a hysterosalpingogram as acutely painful since it involves placement of a cervical tenaculum, traction on the cervix, and instillation of dye through a cervical cannula. Different techniques have been employed to attempt to make the procedure less painful, including use of balloon catheters rather than cannulas; however, this has not been shown to be uniformly effective. Previous studies have shown a reduction in overall pain during HSG after pre-medication with oral non-steroidal anti-inflammatory drugs. Benzocaine gel (20%) applied to the cervix has also been shown to reduce pain. Conversely, a study of pre-medication with paracetamol (acetaminophen) showed no statistical improvement in pain perception. Additionally, transcervical intrauterine instillation of lidocaine has been shown in randomized studies to not improve pain scores and may actually increase pain after the procedure is complete A MEDLINE literature search of papers written in English from January 1966 to August 2005, using the keywords "hysterosalpingogram," "analgesia", "paracervical," and "intracervical" did not reveal any prior studies on the use of an intracervical block prior to hysterosalpingography. A paracervical block has been shown to decrease pain with therapeutic abortions, endometrial biopsy, and office hysteroscopy (7, 8). We hypothesized that an intracervical block would also decrease pain during a hysterosalpingogram. A three armed, randomized controlled trial comparing pain control after a 1% lidocaine intracervical block, saline injection or no injection in patients undergoing hysterosalpingogram was performed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients without a known cause for their infertility who were undergoing a hysterosalpingogram were eligible for enrollment.\n* All subjects were 18 to 40 years of age and married.\n\nExclusion Criteria:\n\n* Included a history of any allergies to local anesthetics, radio-opaque dye or to anti-inflammatory medications.'}, 'identificationModule': {'nctId': 'NCT00372658', 'briefTitle': 'Intracervical Block Versus Placebo to Assess Pain Control During Hysterosalpingogram', 'organization': {'class': 'FED', 'fullName': '59th Medical Wing'}, 'officialTitle': 'Intracervical Block and Pain Perception During the Performance of a Hysterosalpingogram: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FWH20010125H'}}, 'armsInterventionsModule': {'interventions': [{'name': '1% Lidocaine intracervical injection', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78236', 'city': 'Lackland Air Force Base', 'state': 'Texas', 'country': 'United States', 'facility': 'Wiford Hall Medical Center', 'geoPoint': {'lat': 29.38663, 'lon': -98.61797}}], 'overallOfficials': [{'name': 'Randal D Robinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wilford Hall Medical Center and Brooke Army Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '59th Medical Wing', 'class': 'FED'}}}}