Numbing Spray for Paracervical Pain

(VAPOR Trial)

Overseen By Mary Tschann, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Queen's Medical Center

Must not be taking: Narcotics, Anxiolytics

Disqualifiers: Allergy to ibuprofen, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Single visit

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a numbing spray called Num Vapocoolant Spray can reduce pain during paracervical blocks, which are numbing injections used in gynecological procedures. Participants will receive either the experimental spray or a placebo (a harmless substance used for comparison) to determine any difference in pain relief. This trial may suit those undergoing a procedure requiring a paracervical block who have not previously used numbing sprays in a medical setting. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

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 is the safety track record for Num Vapocoolant Spray?

Research shows that vapocoolant sprays, such as Num Vapocoolant Spray, are generally safe. These sprays help reduce pain during procedures like injections, and no major side effects have been reported when applied to the skin.

The FDA has approved Num Vapocoolant Spray for use on the skin before injections, confirming its safety in these situations. This study examines its effectiveness in reducing pain during gynecological procedures. Although this is a new application, it still relies on its established safety record. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Num Vapocoolant Spray because it offers a new approach to managing paracervical pain. Unlike traditional treatments that may involve oral painkillers or local anesthetics, this spray uses a vapocoolant to numb the area quickly. The spray is applied directly to the cervix, providing fast and targeted relief without the need for needles or systemic medication. This could be a game-changer for those seeking a less invasive and more immediate way to manage pain during gynecologic procedures.

What evidence suggests that Num Vapocoolant Spray might be an effective treatment for paracervical pain?

This trial will compare the effectiveness of Num Vapocoolant Spray with a placebo spray, Natures Tears, for reducing pain during paracervical blocks. Studies have shown that vapocoolant sprays, such as Num Vapocoolant Spray, can significantly reduce pain during medical procedures. A review of 11 studies involving 1,410 patients found that these sprays helped lessen pain during procedures like IV insertion. Research indicates that this cooling spray works by quickly numbing the skin, which helps reduce pain. Although its exact effects on gynecological procedures remain unclear, existing evidence suggests it could effectively reduce pain during paracervical blocks. ^{2 3 6 7 8}

Who Is on the Research Team?

Mary Tschann, PhD

Principal Investigator

University of Hawaii

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Num Vapocoolant Spray Experimental Treatment 1 Intervention

This is the intervention arm.

Group II: Natures Tears Placebo Group 1 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.

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+

Published Research Related to This Trial

In a study involving 88 young male blood donors, the use of vapocoolant spray significantly reduced pain during venipuncture, with an average pain score of 1.90 for the spray group compared to 3.23 for the control group (P = .02).

The results indicate that vapocoolant spray is an effective pain management technique for blood donation, enhancing the comfort of donors during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors: A Randomized Controlled Trial. Basak, T., Aciksoz, S., Savasci, U., et al.[2021]

Vapocoolant sprays are used to manage pain during the access of totally implanted venous access devices (TIVADs), but there is currently no clear indication or contraindication for their use, highlighting a gap in clinical guidelines.

The article aims to evaluate the safety and effectiveness of vapocoolant sprays in the TIVAD access process, emphasizing the need for best practices that consider product use, institutional policies, and individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vapocoolant Sprays: Use With Totally Implanted Venous Access Devices. Bostelman, C.[2019]

In a study involving 50 patients, the use of alkane vapocoolant spray after standard skin disinfection did not significantly increase bacterial counts, indicating it does not recontaminate the skin before intravenous cannulation.

The vapocoolant spray demonstrated a significant bactericidal effect on unprepared skin, reducing bacterial colony counts, but it should not replace standard disinfection methods as it is not sufficient as a sole disinfectant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of vapocoolant spray on skin sterility prior to intravenous cannulation. Evans, JG., Taylor, DM., Hurren, F., et al.[2015]

In a study of 300 adults, the use of vapocoolant spray significantly reduced pain during peripheral intravenous (PIV) cannulation compared to a placebo, with a median pain score of 2 for the vapocoolant group versus 4 for the placebo group (P<0.001).

The vapocoolant was well tolerated with minimal side effects, such as slight erythema in 2.7% of patients, which resolved quickly, and there were no significant changes in vital signs or visible skin abnormalities after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, double blind, randomized, controlled trial comparing vapocoolant spray versus placebo spray in adults undergoing intravenous cannulation. Mace, SE.[2019]

In a study of 77 patients undergoing uterine aspiration, the addition of 10% lidocaine spray to a paracervical block significantly reduced perceived pain during the procedure, with a mean Visual Analog Scale (VAS) score of 2.35 cm compared to 6.56 cm for the paracervical block alone.

The results indicate that using lidocaine spray alongside a paracervical block is a safe and effective method to enhance pain management during first-trimester surgical abortions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lidocaine spray in addition to paracervical block reduces pain during first-trimester surgical abortion: a placebo-controlled clinical trial. Karasahin, KE., Alanbay, I., Ercan, CM., et al.[2013]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. Mody, SK., Farala, JP., Jimenez, B., et al.[2022]

Topical benzocaine 20% gel significantly reduced pain during various gynecologic procedures, with 40 women reporting less pain compared to 42 control subjects, showing a strong statistical significance (P < .05 to P < .0005).

In a blind comparison with a placebo gel involving 63 study subjects, the majority of patients rated their pain as 'none' after procedures, indicating that benzocaine is effective for pain management in gynecologic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical anesthesia for gynecologic procedures. Rabin, JM., Spitzer, M., Dwyer, AT., et al.[2019]

In a study of 140 women undergoing fractional curettage, lidocaine provided significantly better pain relief compared to plain saline, particularly during the procedure (P = .02).

The use of lidocaine was safe, with no serious adverse effects reported, and its effectiveness is attributed to its ability to mechanically distend tissue and block peripheral nerves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lidocaine versus plain saline for pain relief in fractional curettage: a randomized controlled trial. Chanrachakul, B., Likittanasombut, P., O-Prasertsawat, P., et al.[2022]

A study involving 20 children aged 2 to 11 years found that a 2.5% lidocaine/prilocaine hydrogel (Nanorap) was well tolerated during cryotherapy for molluscum contagiosum, with minimal adverse effects.

Only two children experienced eczema at the application site, which were unlikely related to the hydrogel, indicating that Nanorap is a safe and effective option for topical anesthesia in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability of 2.5% Lidocaine/Prilocaine Hydrogel in Children Undergoing Cryotherapy for Molluscum Contagiosum. Gobbato, AA., Babadópulos, T., Gobbato, CA., et al.[2017]

In a study of 72 adult patients in an emergency department, the use of a topical anesthetic spray (vapocoolant) did not significantly reduce pain or anxiety during peripheral intravenous (PIV) catheter insertion compared to a placebo.

Despite the lack of significant differences in pain relief, a high percentage of both patients (89%) and nurses (74%) expressed a willingness to use the vapocoolant spray in future procedures, indicating a preference for its use even without measurable efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blind Trial to Determine if Vapocoolant in the Adult Population Improves Patient Perception of Pain With Peripheral Intravascular Access. Edwards, C., Noah, C.[2018]

In a study involving 57 preschoolers aged 4 to 6, the use of vapocoolant for pain relief during immunization injections was found to be ineffective, as self-reported pain levels increased more in the vapocoolant group compared to typical care.

Other pain measurement methods also indicated significant increases in pain during injections, confirming that vapocoolant does not provide effective pain management for intramuscular injections in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of vapocoolant for pediatric immunization distress relief. Cohen, LL., MacLaren, JE., DeMore, M., et al.[2013]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Chudnoff, S., Einstein, M., Levie, M.[2021]

In a study of 95 pediatric patients aged 9 to 18, vapocoolant spray was found to be potentially more effective than topical ice packs for reducing pain during intravenous catheter placement, as indicated by greater changes in visual analog scale (VAS) scores.

Patients using vapocoolant spray reported higher satisfaction with their pain management (76% felt it worked well) compared to those using ice packs (49%), and both methods did not affect the success rate of IV insertions (83% successful).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryotherapeutic topical analgesics for pediatric intravenous catheter placement: ice versus vapocoolant spray. Waterhouse, MR., Liu, DR., Wang, VJ.[2022]

Citations

1. withpower.com withpower.com/trial/phase-4-pain-with-gynecology-procedure-1-2024-9ca71

Numbing Spray for Paracervical Pain (VAPOR Trial) The purpose of this study is to assess if Num vapocoolant spray decreases pain associated with paracervical block in gynecology procedures. Show more. Will I ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/52/NCT06227052/Prot_SAP_000.pdf

of 25 Version 1-15-2024 Research Study Protocol Title Outcomes: We hypothesize that the vapocoolant spray will decrease patients' pain at the time of the paracervical block and tenaculum placement.

3. ctv.veeva.com ctv.veeva.com/study/applying-num-vapocoolant-spray-to-cervix-before-paracervical-block-to-decrease-pain-during-gynecolog

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

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34418716/

Evaluation of vapocoolant spray effect on pain reduction ... This prospective, randomized clinical study was conducted to evaluate the effectiveness of vapocoolant spray application in reducing pain during digital block.

5. 623medical.com 623medical.com/resources

Resources This meta-analysis (11 randomized controlled trials with 1410 patients) suggests that vapocoolant spray significantly decreased pain during intravenous ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K202782.pdf

December 21, 2020 623 Medical, LLC James Fentress ... The num device is provided sterile single-dose container. When the spray actuator is depressed by the end user, the vapocoolant mixture travels.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4460942/

Adverse Effects of Vapocoolant and Topical Anesthesia for ... Our findings indicate that vapocoolant, topical anesthesia, and inhaled isoflurane do not enhance the wellbeing of preweanling mice undergoing tail biopsy.

8. clinicaltrial.be clinicaltrial.be/en/details/423093?only_active=0&only_eligible=0&only_recruiting=0&per_page=100

Applying Num Vapocoolant Spray to Cervix Before ... Num Vapocoolant spray is currently FDA approved to be used on skin prior to injections. The investigators are using it in the same fashion but ...