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
| Type | Name | Description |
|---|---|---|
| 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. 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. |
| OTHER | Placebo | This 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.