Clinical trial NCT00372658: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Keywords: hysterosalpingogram
intracervical local anesthesia
pain perception
visual analogue scale
Lead sponsor: 59th Medical Wing
Sponsor class: FED
First posted: 2006-09-07
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual analogue and qualitative scales to assess study participants pain at 6 different time points during the hysterosalpingogram.
Secondary outcomes:
measure: Anatomical result of the hysterosalpingogram were also collected for a sub-group analysis to evaluate if particular pathology had an effect on pain scores.
Other outcomes:
Locations:
city: Lackland AFB
country: United States
facility: Wiford Hall Medical Center
state: Texas
Study officials:
affiliation: Wilford Hall Medical Center and Brooke Army Medical Center
name: Randal D Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.