98 Participants Needed

Numbing Spray for Paracervical Pain

(VAPOR Trial)

LR
MT
Overseen ByMary Tschann, PhD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: Queen's Medical Center
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess if Num vapocoolant spray decreases pain associated with paracervical block in gynecology procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you require narcotics, anxiolytics, or certain types of anesthesia for the procedure, you may not be eligible to participate.

What data supports the effectiveness of the treatment Num Vapocoolant Spray for paracervical pain?

The research on topical benzocaine gel, which is similar to a numbing spray, shows it significantly reduces pain during gynecologic procedures, suggesting that a numbing spray like Num Vapocoolant Spray could also be effective for paracervical pain.12345

Is the numbing spray safe for use in humans?

Research on vapocoolant sprays, used for reducing pain during procedures like intravenous access, shows they are generally safe with no significant side effects reported, such as skin issues or long-term problems.678910

How does the numbing spray treatment for paracervical pain differ from other treatments?

The numbing spray treatment for paracervical pain is unique because it uses a vapocoolant spray, which provides rapid pain relief by cooling the skin and temporarily interrupting pain sensation without the need for needles or long waiting times, unlike traditional local anesthetics.711121314

Research Team

MT

Mary Tschann, PhD

Principal Investigator

University of Hawaii

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for a procedure that needs a local anesthetic near my cervix.
English-speaking
Able and willing to sign the informed consent form and agree to terms of the study

Exclusion Criteria

I need strong painkillers, anxiety medication, IV sedation, or general anesthesia for my procedure.
Declines or has a contraindication/allergy to ibuprofen
I have been treated with a cooling spray for pain in a medical setting before.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Num vapocoolant spray or placebo during their gynecologic procedure just before the paracervical block

Single visit
1 visit (in-person)

Follow-up

Participants are monitored for pain and satisfaction immediately after the procedure

Immediately post-procedure
1 visit (in-person)

Treatment Details

Interventions

  • Num Vapocoolant Spray
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Queen's Medical Center

Lead Sponsor

Trials
24
Recruited
4,900+

Lakshmi Devi and Devraj Sharma Endowment

Collaborator

Trials
1
Recruited
100+

Findings from Research

In a study of 82 women undergoing first trimester aspiration abortions, chloroprocaine was found to significantly reduce pain compared to saline, with average pain scores of 6.3 versus 7.8 on a 0-10 scale.
The placement of the paracervical block did not affect pain levels, and using a four-site injection technique did not provide any additional benefits over a two-site approach.
Comparison of paracervical block techniques during first trimester pregnancy termination.Glantz, JC., Shomento, S.[2019]
A paracervical block using 1% lidocaine significantly reduces pain during cervical manipulations in office hysteroscopic sterilization, with lower pain scores reported for tenaculum placement and traversing the cervical os compared to saline.
However, the lidocaine block does not alleviate pain associated with the placement of devices in the upper uterine/tubal area, indicating its effectiveness is limited to certain procedural steps.
Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial.Chudnoff, S., Einstein, M., Levie, M.[2021]
A 20-mL buffered 1% lidocaine paracervical block significantly reduces pain during intrauterine device (IUD) placement, with participants reporting a median pain score of 33 mm compared to 54 mm in the no-block group.
While the paracervical block itself caused more pain during administration (30 mm vs 8 mm), the overall pain perception for the IUD placement procedure was lower in the block group, indicating its efficacy despite the initial discomfort.
Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial.Mody, SK., Farala, JP., Jimenez, B., et al.[2022]

References

Comparison of paracervical block techniques during first trimester pregnancy termination. [2019]
Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. [2021]
Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. [2022]
Topical anesthesia for gynecologic procedures. [2019]
Lidocaine versus plain saline for pain relief in fractional curettage: a randomized controlled trial. [2022]
Vapocoolant Sprays: Use With Totally Implanted Venous Access Devices. [2019]
Prospective, double blind, randomized, controlled trial comparing vapocoolant spray versus placebo spray in adults undergoing intravenous cannulation. [2019]
Tolerability of 2.5% Lidocaine/Prilocaine Hydrogel in Children Undergoing Cryotherapy for Molluscum Contagiosum. [2017]
A Randomized, Double-Blind Trial to Determine if Vapocoolant in the Adult Population Improves Patient Perception of Pain With Peripheral Intravascular Access. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
A randomized controlled trial of vapocoolant for pediatric immunization distress relief. [2013]
Effects of vapocoolant spray on skin sterility prior to intravenous cannulation. [2015]
12.United Statespubmed.ncbi.nlm.nih.gov
Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors: A Randomized Controlled Trial. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Cryotherapeutic topical analgesics for pediatric intravenous catheter placement: ice versus vapocoolant spray. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Lidocaine spray in addition to paracervical block reduces pain during first-trimester surgical abortion: a placebo-controlled clinical trial. [2013]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security