NCT00372658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
Last Updated

September 7, 2006

Status Verified

December 1, 2005

First QC Date

September 5, 2006

Last Update Submit

September 6, 2006

Conditions

Infertility

Keywords

hysterosalpingogramintracervical local anesthesiapain perceptionvisual analogue scale

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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.

Interventions

1% Lidocaine intracervical injectionDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wiford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

Related Publications (1)

  • 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.

    PMID: 17197592DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Randal D Robinson, MD

    Wilford Hall Medical Center and Brooke Army Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

September 5, 2006

First Posted

September 7, 2006

Study Start

July 1, 2002

Study Completion

October 1, 2004

Last Updated

September 7, 2006

Record last verified: 2005-12

Locations

US(1)