Status and phase
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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
Sex
Ages
Volunteers
Inclusion criteria
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
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 purpose
Allocation
Interventional model
Masking
98 participants in 2 patient groups, including a placebo group
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Central trial contact
Lule Rault, MD; Mary Tschann, PhD
Data sourced from clinicaltrials.gov
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