Benzocaine Versus Placebo Spray for Pain Relief at Hysterosalpingogram

Analgesia Clinical Trial

Official title:

A Randomized Controlled Trial of Benzocaine Versus Placebo Spray for Pain Relief at Hysterosalpingogram

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925469
• Other study ID #: PFC-HSG-1
• Status: Completed
• Phase: Phase 4
• First received: August 6, 2013
• Last updated: August 22, 2013
• Start date: December 2011
• Est. completion date: April 2012

Study information

• Verified date: August 2013
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: University of Pennsylvania IRB
• Study type: Interventional

Clinical Trial 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).

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesia
• Pain Relief

Intervention

Drug:
• Benzocaine

• Saline spray
A saline spray will be used in the placebo group

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain score	The primary outcome is the difference in pain score using a validated visual analog scale before the procedure, which is designated as the pre-procedure (or baseline) pain score to the maximum pain during procedure (designated as time 0) These two pain scores will be subtracted and the change in pain score will be reported.	Pre-procedure (Baseline) and procedure (Time 0)	No
Secondary	Patient satisfaction	The patient's satisfaction will be assessed using a validated satisfaction scale 30 minutes post procedure.	30 minutes post procedure	No
Secondary	Change in pain score from pre-procedure to 5 and 30 minutes post procedure	The patients pain scores will also be assessed at 5 and 30 minutes post procedure and the change in pain scores from baseline to these time points will be analyzed. The pain scores will be subtracted to obtain the change in pain score	5 minutes and 30 minutes	No