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Completed

NCT Number: NCT06227052

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

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

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Key information

Conditions

Pain With Paracervical Block Neurologic Manifestations Pain Pain With Gynecology Procedure Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Queens Medical Center POB1 Clinic 1004

Honolulu, Hawaii, 96813, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Num Vapocoolant Spray

Device

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. The investigators are using it in the same fashion but in the vagina on the cervix to help with the pain of the paracervical block injection.

Placebo

Other

This is the placebo. This group will receive Natures tear normal saline spray.

Primary outcomes

  1. Pain With Paracervical Block

    Time frame: Immediately after paracervical block (0 minutes after PCB completed)

    The investigators will ask patients to rate their pain with the paracervical block using a visual analog scale (VAS). The visual analog scale is 100 mm line, with values 0 to 100. 0 is marked as no pain, 100 is marked as worst pain.

Secondary outcomes

  1. Patient Satisfaction With Procedure

    Time frame: Immediately after their gynecologic procedure (0 minutes after procedure completed)

    The investigators 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). The visual analog scale is 100 mm line, with values 0 to 100. 0 is marked as not satisfied, 100 is marked as extremely satisfied.

  2. Provider Ease of Use

    Time frame: Within 5 minutes after patient procedure

    Immediately after the patients gynecologic procedure, the research coordinators will ask the provider how easy it was to use the spray. The provider will use a visual analog scale. The visual analog scale is 100 mm line, with values 0 to 100. 0 is marked as not easy to use, 100 is marked as easy to use.

  3. Other Pain Points During Gynecology Procedure

    Time frame: Baseline pain (immediately before procedure), after tenaculum (0 minutes after tenaculum placed), and 5 minutes after procedure

    The investigators 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, Five minutes post-procedure. The visual analog scale is 100 mm line, with values 0 to 100. 0 is marked as no pain, 100 is marked as worst pain.

  4. Pre Procedure Anxiety

    Time frame: Immediately after enrollment - before procedure

    The investigators will also ask the patient how anxious they are before the procedure using the Visual Analog Scale (VAS). The visual analog scale is 100 mm line, with values 0 to 100. 0 is marked as no anxiety, 100 is marked as anxious.

Sponsors and collaborators

Lead sponsor

Queen's Medical Center

Other

Collaborators

  • Lakshmi Devi and Devraj Sharma Endowment

Registry information

Official study title

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

Acronym: VAPOR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2024
Registry last updated
Sep 25, 2025

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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