Applying Num Vapocoolant Spray to Cervix Before Paracervical Block to Decrease Pain During Gynecology Procedures (VAPOR)

January 17, 2024 updated by: Catherine Rault, Queen's Medical Center

Vapocoolant Application for Pain Reduction During Office-based Gynecologic Procedures: a Randomized Controlled Trial (VAPOR)

The purpose of this study is to assess if Num vapocoolant spray decreases pain associated with paracervical block in gynecology procedures.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

After patients seen in our clinic have decided to proceed with a gynecology procedure that requires a paracervical block, the doctor will evaluate if the patient meets eligibility criteria for this study. If the patient does meet eligibility criteria, the doctor will inform the patient about the study and the potential risks. All patients will be given written informed consent. If the patient decides to participate in the study, they will be randomized (patient blinded) to receive either Num vapocoolant spray or placebo (normal saline spray), which the patient will receive during their gynecologic procedure just before the paracervical block. The purpose of this study is to see if the Num vapocoolant spray decreases patients pain with the paracervical block.

Study Type

Interventional

Enrollment (Estimated)

98

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queens Medical Center POB1 Clinic 1004
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lule Rault, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18 years of age or older

Undergoing a procedure requiring paracervical block

English-speaking

Able and willing to sign the informed consent form and agree to terms of the study

Exclusion Criteria:

  • Required or requested narcotics, anxiolytics, IV sedation, or general anesthesia for the procedure

Declines or has a contraindication/allergy to ibuprofen

Previously received vapocoolant spray in a medical setting

Contraindications or allergies to lidocaine for paracervical block or vapocoolant spray components (1,1,3,3-pentafluoropropaine or 1,1,1,2-tetrafluroethane)

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Natures Tears
This is the placebo arm. Participants in this arm will receive Natures Tears spray during their gynecologic procedure. They will receive the spray on their cervix right before the paracervical block. Natures Tears is normal saline, which is sprayed from a canister similar to the Num vapocoolant.
Other: Placebo
This is the placebo. This group will receive Natures tear normal saline spray.
Experimental: Num Vapocoolant Spray
This is the intervention arm.
Device: Num Vapocoolant Spray
This is the study arm. Partipants in this arm will receive Num vapocoolant spray during their gynecologic procedure. They will receive the spray on their cervix right before the paracervical block. Num Vapocoolant spray is currently FDA approved to be used on skin prior to injections. We are using it in the same fashion but in the vagina on the cervix to help with the pain of the paracervical block injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain with Paracervical Block
Time Frame: Immediately after paracervical block
We will ask patients to rate their pain with the paracervical block using a visual analog scale (VAS).
Immediately after paracervical block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction with Procedure
Time Frame: Immediately after their gynecologic procedure
We will also ask patients after their gynecologic procedure how satisfied they were with the procedure and the pain control during the procedure using a Visual Analog Scale (VAS).
Immediately after their gynecologic procedure
Provider Ease of Use
Time Frame: Immediately after the patient's procedure.
Immediately after the patients gynecologic procedure, the research coordinators will ask the provider how easy it was to use the spray.
Immediately after the patient's procedure.
Other Pain Points During Gynecology Procedure
Time Frame: Immediately before, during and after gynecologic procedure.
We will also look at a patients reported pain using the Visual Analog Scale (VAS) during other times of the procedure. Specifically: Prior to the start of the procedure (baseline) After tenaculum placement, After gynecologic procedure complete Five minutes post-procedure .
Immediately before, during and after gynecologic procedure.
Pre Procedure Anxiety
Time Frame: Immediately after enrollment - before procedure
We will also ask the patient how anxious they are before the procedure using the Visual Analog Scale (VAS).
Immediately after enrollment - before procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's Medical Center

Collaborators

Lakshmi Devi and Devraj Sharma Endowment

Investigators

  • Study Chair: Mary Tschann, PhD, University of Hawaii

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.

General Publications

Helpful Links

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 (Estimated)

February 5, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Estimated)

January 26, 2024

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VAPOR1004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Contact corresponding author regarding access to IPD.

IPD Sharing Time Frame

If interested, please contact corresponding author to access IPD.

IPD Sharing Access Criteria

Criteria for accessing IPD will be established at the conclusion of the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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