Intracervical Block Versus Placebo to Assess Pain Control During Hysterosalpingogram

September 6, 2006 updated by: 59th Medical Wing

Intracervical Block and Pain Perception During the Performance of a Hysterosalpingogram: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Lackland AFB, Texas, United States, 78236
        • Wiford Hall Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

59th Medical Wing

Investigators

  • Principal Investigator: Randal D Robinson, MD, Wilford Hall Medical Center and Brooke Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion

October 1, 2004

Study Registration Dates

First Submitted

September 5, 2006

First Submitted That Met QC Criteria

September 6, 2006

First Posted (Estimate)

September 7, 2006

Study Record Updates

Last Update Posted (Estimate)

September 7, 2006

Last Update Submitted That Met QC Criteria

September 6, 2006

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20010125H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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