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Intracervical Block Versus Placebo to Assess Pain Control During Hysterosalpingogram

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00372658
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : September 7, 2006
Information provided by:
Wilford Hall Medical Center

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: 1% Lidocaine intracervical injection Phase 2

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 Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Intracervical Block and Pain Perception During the Performance of a Hysterosalpingogram: A Randomized Controlled Trial
Study Start Date : July 2002
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine

Primary Outcome Measures :
  1. Visual analogue and qualitative scales to assess study participants pain at 6 different time points during the hysterosalpingogram.

Secondary Outcome Measures :
  1. Anatomical result of the hysterosalpingogram were also collected for a sub-group analysis to evaluate if particular pathology had an effect on pain scores.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • All patients without a known cause for their infertility who were undergoing a hysterosalpingogram were eligible for enrollment.
  • All subjects were 18 to 40 years of age and married.

Exclusion Criteria:

  • Included a history of any allergies to local anesthetics, radio-opaque dye or to anti-inflammatory medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00372658

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United States, Texas
Wiford Hall Medical Center
Lackland AFB, Texas, United States, 78236
Sponsors and Collaborators
Wilford Hall Medical Center
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Principal Investigator: Randal D Robinson, MD Wilford Hall Medical Center and Brooke Army Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00372658     History of Changes
Other Study ID Numbers: FWH20010125H
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: September 7, 2006
Last Verified: December 2005
Keywords provided by Wilford Hall Medical Center:
intracervical local anesthesia
pain perception
visual analogue scale
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action