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Intracervical Block Versus Placebo to Assess Pain Control During Hysterosalpingogram

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
1% Lidocaine intracervical injection
Sponsored by
59th Medical Wing
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring hysterosalpingogram, intracervical local anesthesia, pain perception, visual analogue scale

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Wiford Hall Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 5, 2006
Last Updated
September 6, 2006
Sponsor
59th Medical Wing
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1. Study Identification

Unique Protocol Identification Number
NCT00372658
Brief Title
Intracervical Block Versus Placebo to Assess Pain Control During Hysterosalpingogram
Official Title
Intracervical Block and Pain Perception During the Performance of a Hysterosalpingogram: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
59th Medical Wing

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
hysterosalpingogram, intracervical local anesthesia, pain perception, visual analogue scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
1% Lidocaine intracervical injection
Primary Outcome Measure Information:
Title
Visual analogue and qualitative scales to assess study participants pain at 6 different time points during the hysterosalpingogram.
Secondary Outcome Measure Information:
Title
Anatomical result of the hysterosalpingogram were also collected for a sub-group analysis to evaluate if particular pathology had an effect on pain scores.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randal D Robinson, MD
Organizational Affiliation
Wilford Hall Medical Center and Brooke Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wiford Hall Medical Center
City
Lackland AFB
State/Province
Texas
ZIP/Postal Code
78236
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17197592
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.
Results Reference
derived

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Intracervical Block Versus Placebo to Assess Pain Control During Hysterosalpingogram

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