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

NCT06227052 | Completed Phase 4 Results

• 1 other identifier: RA-2023-046 VAPOR1004
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain With Paracervical Block; Pain With Gynecology Procedure; Pain

Keywords

Pain with Paracervical Block; Pain with Gynecology Procedure; Num Vapocoolant Spray; Vapocoolant Spray; Vapocoolant

Outcome Measures

Primary Outcomes (1)

• Pain With Paracervical Block

  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.

  Immediately after paracervical block (0 minutes after PCB completed)

Secondary Outcomes (4)

• Patient Satisfaction With Procedure

  Immediately after their gynecologic procedure (0 minutes after procedure completed)

• Provider Ease of Use

  Within 5 minutes after patient procedure

• Other Pain Points During Gynecology Procedure

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

• Pre Procedure Anxiety

  Immediately after enrollment - before procedure

Study Arms (2)

Natures Tears

PLACEBO COMPARATOR

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

Num Vapocoolant Spray

EXPERIMENTAL

This is the intervention arm.

Device: Num Vapocoolant Spray

Interventions

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.

Num Vapocoolant Spray

Placebo OTHER

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

Natures Tears

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Queen's Medical Center: lead
• Lakshmi Devi and Devraj Sharma Endowment: collaborator

Study Sites (1)

Queens Medical Center POB1 Clinic 1004

Honolulu, Hawaii, 96813, United States

Location

Related Publications (17)

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Related Links

• Num Vapocoolant Website

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Catherine Rault
• Organization: Queen's Medical Center

crault@hawaii.edu

808-686-4690

Study Officials

• Mary Tschann, PhD

  University of Hawaii

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Research coordinators who will be collecting pain scales from patients will be blinded to intervention assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Complex Family Planning Fellow

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: February 5, 2024
• Primary Completion: March 7, 2025
• Study Completion: March 7, 2025
• Last Updated: September 25, 2025
• Results First Posted: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: If interested, please contact corresponding author to access IPD.
• Access Criteria: Criteria for accessing IPD will be established at the conclusion of the study.

Locations

US (1)