NCT01925469

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

April 28, 2017

Completed
Last Updated

April 28, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

August 6, 2013

Results QC Date

December 17, 2013

Last Update Submit

March 17, 2017

Conditions

Pain ReliefAnalgesia

Keywords

HysterosalpingogramHSGPain reliefAnalgesiaBenzocaine

Outcome Measures

Primary Outcomes (1)

  • 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. 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 Outcomes (2)

  • Patient Satisfaction

    30 minutes post procedure

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

    5 minutes

Study Arms (2)

Benzocaine

EXPERIMENTAL

Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.

Drug: Benzocaine

Saline spray

PLACEBO COMPARATOR

A saline placebo spray will be used in the placebo group.

Drug: Saline spray

Interventions

BenzocaineDRUG
Benzocaine
Saline sprayDRUG

A saline spray will be used in the placebo group

Saline spray

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 24745839DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Benzocaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

para-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Limitations and Caveats

Standard deviations were wider than anticipated.

Results Point of Contact

Title
Dr. Emelia Bachman
Organization
University of Pennsylvania
emeliacleo@gmail.com
443-955-9195

Study Officials

  • Suleena K Kalra, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2013

First Posted

August 19, 2013

Study Start

December 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 28, 2017

Results First Posted

April 28, 2017

Record last verified: 2017-03

Locations

US(1)