Intracervical Block Versus Placebo to Assess Pain Control During Hysterosalpingogram

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372658
• Other study ID #: FWH20010125H
• Status: Completed
• Phase: Phase 2
• First received: September 5, 2006
• Last updated: September 6, 2006
• Start date: July 2002
• Est. completion date: October 2004

Study information

• Verified date: December 2005
• Source: Wilford Hall Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• 1% Lidocaine intracervical injection

Locations

Country	Name	City	State
United States	Wiford Hall Medical Center	Lackland AFB	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Wilford Hall Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue and qualitative scales to assess study participants pain at 6 different time points during the hysterosalpingogram.
Secondary	Anatomical result of the hysterosalpingogram were also collected for a sub-group analysis to evaluate if particular pathology had an effect on pain scores.