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| Name | Class |
|---|---|
| Lakshmi Devi and Devraj Sharma Endowment | UNKNOWN |
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The purpose of this study is to assess if Num vapocoolant spray decreases pain associated with paracervical block in gynecology procedures.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Num Vapocoolant Spray | Experimental | This is the intervention arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Num Vapocoolant Spray | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after paracervical block (0 minutes after PCB completed) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after their gynecologic procedure (0 minutes after procedure completed) |
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Mary Tschann, PhD | University of Hawaii | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queens Medical Center POB1 Clinic 1004 | Honolulu | Hawaii | 96813 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31666302 | Background | 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. | |
| 19119169 | Background | Kosaraju 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. |
| Label | URL |
|---|---|
| Num Vapocoolant Website | View source |
Not provided
Contact corresponding author regarding access to IPD.
If interested, please contact corresponding author to access IPD.
Criteria for accessing IPD will be established at the conclusion of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Natures Tears | 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. Placebo: This is the placebo. This group will receive Natures tear normal saline spray. |
| FG001 | Num Vapocoolant Spray | This is the intervention arm. Num Vapocoolant Spray: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Natures Tears | 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. Placebo: This is the placebo. This group will receive Natures tear normal saline spray. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Immediately after paracervical block (0 minutes after PCB completed) |
|
1 week postprocedure
Adverse events were captured in a few ways:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Natures Tears | 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. Placebo: This is the placebo. This group will receive Natures tear normal saline spray. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal itching | Reproductive system and breast disorders | Non-systematic Assessment | ED with vaginal itching for 2 days, prescribed clotrimazole/betamethasone. CT test positive after ED. Rx sent in by us as part of follow up for AE. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Rault | Queen's Medical Center | 808-686-4690 | crault@hawaii.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2024 | Sep 4, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 15, 2024 | Sep 4, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Research coordinators who will be collecting pain scales from patients will be blinded to intervention assignment.
|
| Placebo | Other | This is the placebo. This group will receive Natures tear normal saline spray. |
|
| 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. | 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. | 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. | Immediately after enrollment - before procedure |
| 27269661 | Background | DiMarco 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. |
| 30253890 | Background | Zhu 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. |
| 34970741 | Background | Isik 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. |
| 36780438 | Background | Wang 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. |
| 34418716 | Background | Selvi 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. |
| 24403926 | Background | Ganji 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. |
| 8169463 | Background | Ernst 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. |
| 30698458 | Background | Unal 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. |
| 24405796 | Background | Goldthwaite 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. |
| 20399943 | Background | Renner 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. |
| 22525915 | Background | Renner 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. |
| 33196038 | Background | Chin 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. |
| 8604867 | Background | Todd 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. |
| 14622683 | Background | Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8. |
| 27235677 | Background | Renner RM, Edelman AB, Nichols MD, Jensen JT, Lim JY, Bednarek PH. Refining paracervical block techniques for pain control in first trimester surgical abortion: a randomized controlled noninferiority trial. Contraception. 2016 Nov;94(5):461-466. doi: 10.1016/j.contraception.2016.05.005. Epub 2016 May 25. |
| BG001 | Num Vapocoolant Spray | This is the intervention arm. Num Vapocoolant Spray: 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Gestational age | Mean | Standard Deviation | days |
|
| Parity | Count of Participants | Participants |
|
| History of vaginal deliveries (1 or more) | Count of Participants | Participants |
|
| History of cesarean section (1 or more) | Count of Participants | Participants |
|
| History of moderate or severe menstrual cramps | Count of Participants | Participants |
|
| Prior gynecologic procedures | Count of Participants | Participants |
|
| Anxiety | Count of Participants | Participants |
|
| Depression | Count of Participants | Participants |
|
| Level of provider | Count of Participants | Participants |
|
| Num Vapocoolant Spray |
This is the intervention arm. Num Vapocoolant Spray: 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. |
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Immediately after their gynecologic procedure (0 minutes after procedure completed) |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Within 5 minutes after patient procedure |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline pain (immediately before procedure), after tenaculum (0 minutes after tenaculum placed), and 5 minutes after procedure |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Immediately after enrollment - before procedure |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Num Vapocoolant Spray | This is the intervention arm. Num Vapocoolant Spray: 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. | 0 | 49 | 0 | 49 | 2 | 49 |
|
| Bleeding | Reproductive system and breast disorders | Non-systematic Assessment | D&C complicated by hemorrhage and re-aspiration. Pt received misoprostol 800 mcg for bleeding in second procedure. Patient tolerated both procedures. Vital signs stable. Hemostasis noted after both initial procedure and re-aspiration. |
|
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| fellow |
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| attending |
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| Pain immediately after procedure |
|
| Pain 5 minutes post op |
|