Benzocaine Versus Placebo Spray for Pain Relief at Hysterosalpingogram

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01925469
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 7.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pain Relief; Analgesia	Drug: Benzocaine; Drug: Saline spray	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of Benzocaine Versus Placebo Spray for Pain Relief at Hysterosalpingogram
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

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.	Drug: Benzocaine
Placebo Comparator: Saline spray A saline placebo spray will be used in the placebo group.	Drug: Saline spray; A saline spray will be used in the placebo group

Outcome Measures

Primary Outcome Measures

1. Change in Pain Score [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 Outcome Measures

1. Patient Satisfaction [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. [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Suleena K Kalra, MD, MSCE, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01925469
• Other Study ID Numbers: PFC-HSG-1
• First Posted: Aug 19, 2013
• Last Update Posted: Apr 28, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by University of Pennsylvania: Hysterosalpingogram; HSG; Pain relief; Analgesia; Benzocaine
• Additional relevant MeSH terms: Benzocaine

Study Results

Participant Flow

Arm/Group Title	Benzocaine	Saline Spray
Arm/Group Description	Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram. Benzocaine	A saline placebo spray will be used in the placebo group. Saline spray: A saline spray will be used in the placebo group
Period Title: Overall Study
STARTED	15	15
COMPLETED	14	15
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Benzocaine	Saline Spray	Total
Arm/Group Description	Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram. Benzocaine	A saline placebo spray will be used in the placebo group. Saline spray: A saline spray will be used in the placebo group	Total of all reporting groups
Overall Participants	15	15	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.3 (4.8)	33.3 (6.5)	33.9 (5.7)
Sex: Female, Male (Count of Participants)
Female	15 100%	15 100%	30 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 6.7%	3 20%	4 13.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 33.3%	6 40%	11 36.7%
White	8 53.3%	6 40%	14 46.7%
More than one race	1 6.7%	0 0%	1 3.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	15 100%	15 100%	30 100%
Nulliparous (participants) [Number]
Number [participants]	12 80%	12 80%	24 80%
Nulligravid (participants) [Number]
Number [participants]	7 46.7%	10 66.7%	17 56.7%
History of dysmenorrhea (participants) [Number]
Number [participants]	7 46.7%	6 40%	13 43.3%
History of chronic pelvic pain (participants) [Number]
Number [participants]	2 13.3%	2 13.3%	4 13.3%
Pre-medication (participants) [Number]
Number [participants]	15 100%	13 86.7%	28 93.3%
Bilateral obstruction (participants) [Number]
Number [participants]	2 13.3%	1 6.7%	3 10%
Unilateral obstruction (participants) [Number]
Number [participants]	4 26.7%	3 20%	7 23.3%

Outcome Measures

1. Primary Outcome

Title	Change in Pain Score
Description	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.
Time Frame	Pre-procedure (Baseline) and procedure (Time 0)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Benzocaine	Saline Spray
Arm/Group Description	Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram. Benzocaine	A saline placebo spray will be used in the placebo group. Saline spray: A saline spray will be used in the placebo group
Measure Participants	15	15
Median (95% Confidence Interval) [mm]	50.6	70.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Benzocaine, Saline Spray
	Comments	An a priori sample size calculation determined at least 28 patients were needed to detect a clinically significant 13 mm difference in pain score (α=0.05, power =0.80) with a standard deviation of 12 mm. Intention to treat analysis was performed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.43
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments	Differences in the median change in pain scores were assessed using Wilcoxon rank sum test.

2. Secondary Outcome

Title	Patient Satisfaction
Description	The patient's satisfaction will be assessed using a validated satisfaction scale 30 minutes post procedure.
Time Frame	30 minutes post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Benzocaine	Saline Spray
Arm/Group Description	Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram. Benzocaine	A saline placebo spray will be used in the placebo group. Saline spray: A saline spray will be used in the placebo group
Measure Participants	15	15
Extremely satisfied	10 66.7%	10 66.7%
Very satisfied	2 13.3%	4 26.7%
Satisfied	2 13.3%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Benzocaine, Saline Spray
	Comments	Fisher exact test was used to assess differences in satisfaction scores by treatment group. Correlation between pain and satisfaction scores was assessed by Spearman's correlation coefficient.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4
	Comments
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Change in Pain Score From Pre-procedure to 5 Minutes Post Procedure.
Description	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
Time Frame	5 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Benzocaine	Saline Spray
Arm/Group Description	Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram. Benzocaine	A saline placebo spray will be used in the placebo group. Saline spray: A saline spray will be used in the placebo group
Measure Participants	15	15
Median (95% Confidence Interval) [mm]	-11.1	-37

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Benzocaine, Saline Spray
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.33
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Arm/Group Title	Benzocaine		Saline Spray
Arm/Group Description	Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram. Benzocaine		A saline placebo spray will be used in the placebo group. Saline spray: A saline spray will be used in the placebo group
All Cause Mortality
	Benzocaine		Saline Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Benzocaine		Saline Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Benzocaine		Saline Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

Standard deviations were wider than anticipated.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.