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| Tracking Information | |||||
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| First Received Date ICMJE | September 5, 2006 | ||||
| Last Updated Date | September 6, 2006 | ||||
| Start Date ICMJE | July 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Visual analogue and qualitative scales to assess study participants pain at 6 different time points during the hysterosalpingogram. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00372658 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Anatomical result of the hysterosalpingogram were also collected for a sub-group analysis to evaluate if particular pathology had an effect on pain scores. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intracervical Block Versus Placebo to Assess Pain Control During Hysterosalpingogram | ||||
| Official Title ICMJE | Intracervical Block and Pain Perception During the Performance of a Hysterosalpingogram: A Randomized Controlled Trial | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Infertility | ||||
| Intervention ICMJE | Drug: 1% Lidocaine intracervical injection | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 120 | ||||
| Completion Date | October 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00372658 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | FWH20010125H | ||||
| Study Sponsor ICMJE | Wilford Hall Medical Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Wilford Hall Medical Center | ||||
| Verification Date | December 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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