Pain With Paracervical BlockPhase 4VAPORNCT06227052
Applying Num Vapocoolant Spray to Cervix Before Paracervical Block to Decrease Pain During Gynecology Procedures
A Phase 4 study testing Num Vapocoolant Spray in people with Pain With Paracervical Block and Pain With Gynecology Procedure, run by Queen's Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess if Num vapocoolant spray decreases pain associated with paracervical block in gynecology procedures. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain With Paracervical Block, Pain With Gynecology Procedure, Pain
- What is being tested?
- Num Vapocoolant Spray
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 7 Mar 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Queens Medical Center POB1 Clinic 1004
Honolulu, Hawaii, 96813
About this study
Official title: Vapocoolant Application for Pain Reduction During Office-based Gynecologic Procedures: a Randomized Controlled Trial (VAPOR)
The purpose of this study is to assess if Num vapocoolant spray decreases pain associated with paracervical block in gynecology procedures.
Read the 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.
- Being tested
- Num Vapocoolant Spray, Placebo
- Keywords
- Pain with Paracervical Block, Pain with Gynecology Procedure, Num Vapocoolant Spray, Vapocoolant Spray, Vapocoolant
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Num Vapocoolant SprayDevice
This is the study arm. Partipants in this arm will receive Num vapocoolant spray during their gynecologic procedure. They will receive the spray on their cervix right before the paracervical block. 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 in the vagina on the cervix to help with the pain of the paracervical block injection.
PlaceboOther
This is the placebo. This group will receive Natures tear normal saline spray.
| Study group | Role | What they receive |
|---|---|---|
| Natures Tears | Placebo comparator | 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. Receives: Other: Placebo |
| Num Vapocoolant Spray | Experimental | This is the intervention arm. Receives: Device: Num Vapocoolant Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain With Paracervical Block
The investigators will ask patients to rate their pain with the paracervical block using a visual analog scale (VAS). The visual analog scale is 100 mm line, with values 0 to 100. 0 is marked as no pain, 100 is marked as worst pain.
Measured: Immediately after paracervical block (0 minutes after PCB completed)
Secondary outcomes (4)
Patient Satisfaction With Procedure
The investigators will also ask patients after their gynecologic procedure how satisfied they were with the procedure and the pain control during the procedure using a Visual Analog Scale (VAS). The visual analog scale is 100 mm line, with values 0 to 100. 0 is marked as not satisfied, 100 is marked as extremely satisfied.
Measured: Immediately after their gynecologic procedure (0 minutes after procedure completed)
Provider Ease of Use
Immediately after the patients gynecologic procedure, the research coordinators will ask the provider how easy it was to use the spray. The provider will use a visual analog scale. The visual analog scale is 100 mm line, with values 0 to 100. 0 is marked as not easy to use, 100 is marked as easy to use.
Measured: Within 5 minutes after patient procedure
Other Pain Points During Gynecology Procedure
The investigators will also look at a patients reported pain using the Visual Analog Scale (VAS) during other times of the procedure. Specifically: Prior to the start of the procedure (baseline) After tenaculum placement, Five minutes post-procedure. The visual analog scale is 100 mm line, with values 0 to 100. 0 is marked as no pain, 100 is marked as worst pain.
Measured: Baseline pain (immediately before procedure), after tenaculum (0 minutes after tenaculum placed), and 5 minutes after procedure
Pre Procedure Anxiety
The investigators will also ask the patient how anxious they are before the procedure using the Visual Analog Scale (VAS). The visual analog scale is 100 mm line, with values 0 to 100. 0 is marked as no anxiety, 100 is marked as anxious.
Measured: Immediately after enrollment - before procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start5 Feb 2024
- Primary completion7 Mar 2025
- Study completion7 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Pain With Paracervical BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lakshmi Devi and Devraj Sharma Endowment
- Responsible party
- Principal investigator, Catherine Rault, Queen's Medical Center
- Investigators
- Mary Tschann, PhD, Study chair, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227052
- Sponsor's protocol ID
- RA-2023-046 VAPOR1004
- Acronym
- VAPOR
- Status last verified
- Sep 2025
- First submitted
- 17 Jan 2024
- Last updated
- 25 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Contact corresponding author regarding access to IPD.
Publications
Lambert T, Truong T, Gray B. Pain perception with cervical tenaculum placement during intrauterine device insertion: a randomised controlled trial. BMJ Sex Reprod Health. 2020 Apr;46(2):126-131. doi: 10.1136/bmjsrh-2019-200376. Epub 2019 Oct 30.
PubMed 31666302Kosaraju A, Vandewalle KS. A comparison of a refrigerant and a topical anesthetic gel as preinjection anesthetics: a clinical evaluation. J Am Dent Assoc. 2009 Jan;140(1):68-72; quiz 112-3. doi: 10.14219/jada.archive.2009.0020.
PubMed 19119169DiMarco AC, Wetmore AO. Clinical Comparison: Fast-Acting and Traditional Topical Dental Anesthetic. Anesth Prog. 2016 Summer;63(2):55-61. doi: 10.2344/0003-3006-63.2.55.
PubMed 27269661Zhu Y, Peng X, Wang S, Chen W, Liu C, Guo B, Zhao L, Gao Y, Wang K, Lou F. Vapocoolant spray versus placebo spray/no treatment for reducing pain from intravenous cannulation: A meta-analysis of randomized controlled trials. Am J Emerg Med. 2018 Nov;36(11):2085-2092. doi: 10.1016/j.ajem.2018.03.068. Epub 2018 Mar 27.
PubMed 30253890Isik MT, Oztunc G. Effects of subcutaneous injection after coolant spray on pain, hematoma, and ecchymosis in three different regions. Nurs Forum. 2022 May;57(3):352-357. doi: 10.1111/nuf.12688. Epub 2021 Dec 30.
PubMed 34970741Wang L, Fang L, Zhou Y, Fang X, Liu J, Qu G. Efficacy and safety of vapocoolant spray for vascular puncture in children and adults: A systematic review and meta-analysis. PLoS One. 2023 Feb 13;18(2):e0279463. doi: 10.1371/journal.pone.0279463. eCollection 2023.
PubMed 36780438Selvi F, Bedel C, Akcimen M. Evaluation of vapocoolant spray effect on pain reduction during digital nerve block: A randomized clinical trial. Am J Emerg Med. 2021 Dec;50:260-263. doi: 10.1016/j.ajem.2021.08.001. Epub 2021 Aug 6.
PubMed 34418716Ganji Z, Shirvani MA, Rezaei-Abhari F, Danesh M. The effect of intermittent local heat and cold on labor pain and child birth outcome. Iran J Nurs Midwifery Res. 2013 Jul;18(4):298-303.
PubMed 24403926Ernst E, Fialka V. Ice freezes pain? A review of the clinical effectiveness of analgesic cold therapy. J Pain Symptom Manage. 1994 Jan;9(1):56-9. doi: 10.1016/0885-3924(94)90150-3.
PubMed 8169463Unal N, Tosun B, Aslan O, Tunay S. Effects of Vapocoolant Spray Prior to SC LMWH Injection: An Experimental Study. Clin Nurs Res. 2021 Feb;30(2):127-134. doi: 10.1177/1054773818825486. Epub 2019 Jan 30.
PubMed 30698458Goldthwaite LM, Baldwin MK, Page J, Micks EA, Nichols MD, Edelman AB, Bednarek PH. Comparison of interventions for pain control with tenaculum placement: a randomized clinical trial. Contraception. 2014 Mar;89(3):229-33. doi: 10.1016/j.contraception.2013.11.018. Epub 2013 Dec 10.
PubMed 24405796Renner RM, Jensen JT, Nichols MD, Edelman AB. Pain control in first-trimester surgical abortion: a systematic review of randomized controlled trials. Contraception. 2010 May;81(5):372-88. doi: 10.1016/j.contraception.2009.12.008. Epub 2010 Jan 27.
PubMed 20399943Renner RM, Nichols MD, Jensen JT, Li H, Edelman AB. Paracervical block for pain control in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2012 May;119(5):1030-7. doi: 10.1097/AOG.0b013e318250b13e.
PubMed 22525915Chin J, Kaneshiro B, Elia J, Raidoo S, Savala M, Soon R. Buffered lidocaine for paracervical blocks in first-trimester abortions: a randomized controlled trial. Contracept X. 2020 Oct 18;2:100044. doi: 10.1016/j.conx.2020.100044. eCollection 2020.
PubMed 33196038Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.
PubMed 8604867
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vapocoolant Application for Pain Reduction During Office-based Gynecologic Procedures: a Randomized Controlled Trial (VAPOR)
- ClinicalTrials.gov ID
- NCT06227052
- Acronym / sponsor ID
- VAPOR / RA-2023-046 VAPOR1004
- Keywords
- Pain with Paracervical Block, Pain with Gynecology Procedure, Num Vapocoolant Spray, Vapocoolant Spray, Vapocoolant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Queen's Medical CenterUniversity, hospital or other
- Collaborators
- Lakshmi Devi and Devraj Sharma Endowment
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 26 Jan 2024 (actual)
- Results
- Posted 25 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natures Tears | Placebo comparator | Other: PlaceboThis 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. |
| Num Vapocoolant Spray | Experimental | Device: Num Vapocoolant SprayThis is the intervention arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Num Vapocoolant SprayThis is the study arm. Partipants in this arm will receive Num vapocoolant spray during their gynecologic procedure. They will receive the spray on their cervix right before the paracervical block. 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 in the vagina on the cervix to help with the pain of the paracervical block injection. | Device | Num Vapocoolant Spray |
| PlaceboThis is the placebo. This group will receive Natures tear normal saline spray. | Other | Natures Tears |
Primary outcome
Pain With Paracervical Block
Time frame: Immediately after paracervical block (0 minutes after PCB completed)
The investigators will ask patients to rate their pain with the paracervical block using a visual analog scale (VAS). The visual analog scale is 100 mm line, with values 0 to 100. 0 is marked as no pain, 100 is marked as worst pain.
4 secondary outcomes
Patient Satisfaction With Procedure
Time frame: Immediately after their gynecologic procedure (0 minutes after procedure completed)
Provider Ease of Use
Time frame: Within 5 minutes after patient procedure
Other Pain Points During Gynecology Procedure
Time frame: Baseline pain (immediately before procedure), after tenaculum (0 minutes after tenaculum placed), and 5 minutes after procedure
Pre Procedure Anxiety
Time frame: Immediately after enrollment - before procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31666302Lambert T, Truong T, Gray B. Pain perception with cervical tenaculum placement during intrauterine device insertion: a randomised controlled trial. BMJ Sex Reprod Health. 2020 Apr;46(2):126-131. doi: 10.1136/bmjsrh-2019-200376. Epub 2019 Oct 30.
- Background: PubMed 19119169Kosaraju A, Vandewalle KS. A comparison of a refrigerant and a topical anesthetic gel as preinjection anesthetics: a clinical evaluation. J Am Dent Assoc. 2009 Jan;140(1):68-72; quiz 112-3. doi: 10.14219/jada.archive.2009.0020.
- Background: PubMed 27269661DiMarco AC, Wetmore AO. Clinical Comparison: Fast-Acting and Traditional Topical Dental Anesthetic. Anesth Prog. 2016 Summer;63(2):55-61. doi: 10.2344/0003-3006-63.2.55.
- Background: PubMed 30253890Zhu Y, Peng X, Wang S, Chen W, Liu C, Guo B, Zhao L, Gao Y, Wang K, Lou F. Vapocoolant spray versus placebo spray/no treatment for reducing pain from intravenous cannulation: A meta-analysis of randomized controlled trials. Am J Emerg Med. 2018 Nov;36(11):2085-2092. doi: 10.1016/j.ajem.2018.03.068. Epub 2018 Mar 27.
- Background: PubMed 34970741Isik MT, Oztunc G. Effects of subcutaneous injection after coolant spray on pain, hematoma, and ecchymosis in three different regions. Nurs Forum. 2022 May;57(3):352-357. doi: 10.1111/nuf.12688. Epub 2021 Dec 30.
- Background: PubMed 36780438Wang L, Fang L, Zhou Y, Fang X, Liu J, Qu G. Efficacy and safety of vapocoolant spray for vascular puncture in children and adults: A systematic review and meta-analysis. PLoS One. 2023 Feb 13;18(2):e0279463. doi: 10.1371/journal.pone.0279463. eCollection 2023.
- Background: PubMed 34418716Selvi F, Bedel C, Akcimen M. Evaluation of vapocoolant spray effect on pain reduction during digital nerve block: A randomized clinical trial. Am J Emerg Med. 2021 Dec;50:260-263. doi: 10.1016/j.ajem.2021.08.001. Epub 2021 Aug 6.
- Background: PubMed 24403926Ganji Z, Shirvani MA, Rezaei-Abhari F, Danesh M. The effect of intermittent local heat and cold on labor pain and child birth outcome. Iran J Nurs Midwifery Res. 2013 Jul;18(4):298-303.
- Background: PubMed 8169463Ernst E, Fialka V. Ice freezes pain? A review of the clinical effectiveness of analgesic cold therapy. J Pain Symptom Manage. 1994 Jan;9(1):56-9. doi: 10.1016/0885-3924(94)90150-3.
- Background: PubMed 30698458Unal N, Tosun B, Aslan O, Tunay S. Effects of Vapocoolant Spray Prior to SC LMWH Injection: An Experimental Study. Clin Nurs Res. 2021 Feb;30(2):127-134. doi: 10.1177/1054773818825486. Epub 2019 Jan 30.
- Background: PubMed 24405796Goldthwaite LM, Baldwin MK, Page J, Micks EA, Nichols MD, Edelman AB, Bednarek PH. Comparison of interventions for pain control with tenaculum placement: a randomized clinical trial. Contraception. 2014 Mar;89(3):229-33. doi: 10.1016/j.contraception.2013.11.018. Epub 2013 Dec 10.
- Background: PubMed 20399943Renner RM, Jensen JT, Nichols MD, Edelman AB. Pain control in first-trimester surgical abortion: a systematic review of randomized controlled trials. Contraception. 2010 May;81(5):372-88. doi: 10.1016/j.contraception.2009.12.008. Epub 2010 Jan 27.
- Num Vapocoolant WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Contact corresponding author regarding access to IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Tschann, PhD study chair
University of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Num Vapocoolant Spray in people with Pain With Paracervical Block and Pain With Gynecology Procedure, run by Queen's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain With Paracervical Block (time frame: Immediately after paracervical block (0 minutes after PCB completed)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06227052, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.