Clinical trial NCT06227052: Applying Num Vapocoolant Spray to Cervix Before Paracervical Block to Decrease Pain During Gynecology Procedures
Official title: Vapocoolant Application for Pain Reduction During Office-based Gynecologic Procedures: a Randomized Controlled Trial (VAPOR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
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
Lead sponsor: Queen's Medical Center
Sponsor class: OTHER
Collaborators: name: Lakshmi Devi and Devraj Sharma Endowment
First posted: 2024-01-26
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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)

Primary outcomes:
measure: Pain with Paracervical Block
timeFrame: Immediately after paracervical block
Secondary outcomes:
measure: Patient Satisfaction with Procedure
timeFrame: Immediately after their gynecologic procedure
measure: Provider Ease of Use
timeFrame: Immediately after the patient's procedure.
measure: Other Pain Points During Gynecology Procedure
timeFrame: Immediately before, during and after gynecologic procedure.
measure: Pre Procedure Anxiety
timeFrame: Immediately after enrollment - before procedure
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Queens Medical Center POB1 Clinic 1004
state: Hawaii
Study officials:
affiliation: University of Hawaii
name: Mary Tschann, PhD
role: STUDY_CHAIR
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