Skip to main content
OpenTrials
Completed

NCT Number: NCT00372658

Intracervical Block Versus Placebo to Assess Pain Control During Hysterosalpingogram

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Wiford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1% Lidocaine intracervical injection

Drug

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.

Sponsors and collaborators

Lead sponsor

59th Medical Wing

Fed

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2004
First posted
Sep 7, 2006
Registry last updated
Sep 7, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.