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Completed

NCT Number: NCT01925469

Benzocaine Versus Placebo Spray for Pain Relief at Hysterosalpingogram

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).

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Key information

Conditions

Pain Relief Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benzocaine

Drug

Saline spray

Drug

A saline spray will be used in the placebo group

Primary outcomes

  1. Change in Pain Score

    Time frame: Pre-procedure (Baseline) and procedure (Time 0)

    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. The validated visual analog scale allows patients to report pain on a scale of 0 to 100 mm long. At the beginning and at the end, there are two descriptors representing extremes of pain (i.e. no pain = 0 and extreme pain = 100). The patient rated her pain by making a vertical mark on the 100-mm line. The measurement in millimeters was converted to the same number of points ranging from 0 to 100 points. There are no subgroups.

Secondary outcomes

  1. Patient Satisfaction

    Time frame: 30 minutes post procedure

    The patient's satisfaction will be assessed using a validated satisfaction scale 30 minutes post procedure.

  2. Change in Pain Score From Pre-procedure to 5 Minutes Post Procedure.

    Time frame: 5 minutes

    The patients pain scores will also be assessed at 5 minutes post procedure and the change in pain scores from baseline to this time points will be analyzed. The pain scores will be subtracted to obtain the change in pain score

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 19, 2013
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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