Clinical Trials Directory

Trials / Completed

CompletedNCT06227052

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

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
98 (actual)
Sponsor
Queen's Medical Center · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DEVICENum Vapocoolant SprayThis 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.
OTHERPlaceboThis is the placebo. This group will receive Natures tear normal saline spray.

Timeline

Start date
2024-02-05
Primary completion
2025-03-07
Completion
2025-03-07
First posted
2024-01-26
Last updated
2025-09-25
Results posted
2025-09-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06227052. Inclusion in this directory is not an endorsement.