Phase 4
N=98
Applying Num Vapocoolant Spray to Cervix Before Paracervical Block to Decrease Pain During Gynecology Procedures
Pain With Paracervical Block · Pain With Gynecology Procedure · Pain
Bottom Line
View on ClinicalTrials.gov: NCT06227052 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Pain With Paracervical Block — 27; 20 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Num Vapocoolant Spray (Device); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Queen's Medical Center
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain With Paracervical Block |
27; 20 | — |
| SECONDARY Patient Satisfaction With Procedure |
91.5; 94; 82; 75 | — |
| SECONDARY Provider Ease of Use |
0; 0 | — |
| SECONDARY Other Pain Points During Gynecology Procedure |
1; 0; 17; 9; 53; 56 | — |
| SECONDARY Pre Procedure Anxiety |
59; 48 | — |
Summary
The purpose of this study is to assess if Num vapocoolant spray decreases pain associated with paracervical block in gynecology procedures.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT06227052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.