Clinical trial NCT01925469: Benzocaine Versus Placebo Spray for Pain Relief at Hysterosalpingogram
Official title: A Randomized Controlled Trial of Benzocaine Versus Placebo Spray for Pain Relief at Hysterosalpingogram
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain Relief
Analgesia
Keywords: Hysterosalpingogram
HSG
Pain relief
Analgesia
Benzocaine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-08-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the utility of benzocaine spray versus a placebo spray in alleviating pain during and after hysterosalpingogram (HSG).

Detailed description: Hysterosalpingography (HSG) is a radiographic evaluation during which a radio-opaque medium is inserted through the cervical canal in order to define the size and shape of the uterine cavity and patency of the fallopian tubes. The utility of HSG is an integral part of the evaluation of infertile women for intrauterine pathology. In some cases, HSG can be a painful procedure. Poor pain control can limit the quality of the study due to inability to complete the procedure in cases of extreme discomfort. There is little consensus regarding pain control during HSG, although a number of approaches have been studied. Patients undergoing HSG are typically advised to premedicate with ibuprofen, which is consistent with the current standard of care. This study will assess pain control using a benzocaine spray (in addition to ibuprofen) in patients undergoing routine HSG at the Hospital of the University of Pennsylvania. All patients who present to the Hospital of the University of Pennsylvania for HSG will be eligible for the study. Benzocaine spray versus a placebo spray will be applied to a tenaculum (a surgical hooklike instrument used to grasp and hold the cervix). The tenaculum will then be applied to the cervix prior to HSG and pain relief will be assessed at 3 time intervals: 0, 5, and 30 minutes. The primary outcome is the mean difference in patients pain score and will be measured using the Visual Analogue Scale (VAS) which has been shown to be a valid and reliable scale. The secondary outcome will assess patient satisfaction in each group using a validated patient satisfaction survey. The study design will be prospective, randomized, placebo controlled, and double blinded.

Eligibility criteria: Inclusion Criteria:

* All women who present to Penn Fertility Care over the age of 18 years old

Exclusion Criteria:

* Patients under the age of 18
* Pregnant patients
* Patients with a history of hypersensitivity to benzocaine
* Patients with a history of asthma or bronchitis

Primary outcomes:
measure: Change in Pain Score
timeFrame: Pre-procedure (Baseline) and procedure (Time 0)
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 30 minutes post procedure
measure: Change in Pain Score From Pre-procedure to 5 Minutes Post Procedure.
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Suleena K Kalra, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bachman EA, Senapati S, Sammel MD, Kalra SK. Randomized controlled trial of benzocaine versus placebo spray for pain relief at hysterosalpingogram. Reprod Biomed Online. 2014 Jun;28(6):748-52. doi: 10.1016/j.rbmo.2014.02.012. Epub 2014 Mar 4.