Intracervical Block Versus Placebo to Assess Pain Control During Hysterosalpingogram

Sponsor

59th Medical Wing (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00372658

Collaborator

(none)

120

Enrollment

Location

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: 1% Lidocaine intracervical injection	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2002

Study Completion Date :

Oct 1, 2004

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.