- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01925469
Benzocaine Versus Placebo Spray for Pain Relief at Hysterosalpingogram
March 17, 2017 updated by: University of Pennsylvania
A Randomized Controlled Trial of 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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Benzocaine
Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.
|
|
Placebo Comparator: Saline spray
A saline placebo spray will be used in the placebo group.
|
A saline spray will be used in the placebo group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Pre-procedure (Baseline) and procedure (Time 0)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction
Time Frame: 30 minutes post procedure
|
The patient's satisfaction will be assessed using a validated satisfaction scale 30 minutes post procedure.
|
30 minutes post procedure
|
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
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Suleena K Kalra, MD, MSCE, University of Pennsylvania
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
August 6, 2013
First Submitted That Met QC Criteria
August 15, 2013
First Posted (Estimate)
August 19, 2013
Study Record Updates
Last Update Posted (Actual)
April 28, 2017
Last Update Submitted That Met QC Criteria
March 17, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PFC-HSG-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Analgesia
-
Mansoura UniversityNot yet recruiting
-
Southeast University, ChinaRecruiting
-
Medical University of South CarolinaRecruiting
-
Southeast University, ChinaRecruiting
-
Huazhong University of Science and TechnologyRecruiting
-
Mansoura UniversityCompleted
-
University of FloridaMdoloris Medical SystemsCompletedAnalgesiaUnited States
-
Mansoura UniversityCompleted
-
Cessatech A/SCompleted
-
Kalyra Pharmaceuticals, Inc.United States Department of Defense; PRA Health SciencesTerminated
Clinical Trials on Benzocaine
-
Cetylite IndustriesCompleted
-
Dina Youssef AttiaCompleted
-
McNeil ABJanssen Pharmaceutica N.V., BelgiumCompletedSore ThroatRussian Federation
-
Cetylite IndustriesCompletedNo Disease State or ConditionUnited States
-
Reckitt Benckiser Healthcare (UK) LimitedWithdrawn
-
B.P. Koirala Institute of Health SciencesCompleted
-
Reckitt Benckiser Healthcare (UK) LimitedRecruiting
-
Tel-Aviv Sourasky Medical CenterTerminatedNeonatal Tongue-tie | Maternal Nipple Pain Upon Breastfeeding | Neonatal Latch DifficultiesIsrael
-
Wyeth is now a wholly owned subsidiary of PfizerChurch & Dwight Company, Inc.; Consumer Healthcare Products AssociationCompleted
-
Aliaa HamoudaRecruitingLocal Anesthesia Injection PainEgypt