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

Q

Queen's Medical Center

Status and phase

Not yet enrolling
Phase 4

Conditions

Pain With Gynecology Procedure
Pain With Paracervical Block

Treatments

Other: Placebo
Device: Num Vapocoolant Spray

Study type

Interventional

Funder types

Other

Identifiers

NCT06227052
VAPOR1004

Details and patient eligibility

About

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

Full 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.

Enrollment

98 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

98 participants in 2 patient groups, including a placebo group

Natures Tears
Placebo Comparator group
Description:
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.
Treatment:
Other: Placebo
Num Vapocoolant Spray
Experimental group
Description:
This is the intervention arm.
Treatment:
Device: Num Vapocoolant Spray

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Mary Tschann, PhD; Lule Rault, MD

Data sourced from clinicaltrials.gov

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