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Numbing Spray for Paracervical Pain (VAPOR Trial)

Phase 4

Recruiting

Research Sponsored by Queen's Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years of age or older

Undergoing a procedure requiring paracervical block

Must not have

Required or requested narcotics, anxiolytics, IV sedation, or general anesthesia for the procedure

Previously received vapocoolant spray in a medical setting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after their gynecologic procedure

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is trying to determine if using a numbing spray called Num can help reduce pain during a specific type of gynecology procedure called a paracervical block.

Who is the study for?

This trial is for individuals experiencing pelvic or paracervical pain during gynecological procedures. Specific eligibility criteria are not provided, so it's best to contact the study organizers for detailed requirements.

What is being tested?

The study aims to determine if Num Vapocoolant Spray can reduce pain when applied to the cervix before a paracervical block, compared with a placebo spray.

What are the potential side effects?

Potential side effects of Num Vapocoolant Spray may include temporary discomfort or skin reactions at the site of application. Detailed side effects are not listed and should be discussed with the research team.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a procedure that needs a local anesthetic near my cervix.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need strong painkillers, anxiety medication, IV sedation, or general anesthesia for my procedure.

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I have been treated with a cooling spray for pain in a medical setting before.

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I am not allergic to lidocaine or the chemicals in certain cooling sprays.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after the patient's procedure.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after the patient's procedure.

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the patient's procedure. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain with Paracervical Block

Secondary study objectives

Other Pain Points During Gynecology Procedure

Patient Satisfaction with Procedure

Pre Procedure Anxiety

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Num Vapocoolant SprayExperimental Treatment1 Intervention

This is the intervention arm.

Group II: Natures TearsPlacebo Group1 Intervention

This is the placebo arm. Participants in this arm will receive Natures Tears spray during their gynecologic procedure. They will receive the spray on their cervix right before the paracervical block. Natures Tears is normal saline, which is sprayed from a canister similar to the Num vapocoolant.

0 / 5Eligibility criteria met