Trial Outcomes & Findings for Applying Num Vapocoolant Spray to Cervix Before Paracervical Block to Decrease Pain During Gynecology Procedures (NCT NCT06227052)
NCT ID: NCT06227052
Last Updated: 2025-09-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
98 participants
Primary outcome timeframe
Immediately after paracervical block (0 minutes after PCB completed)
Results posted on
2025-09-25
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
|
Overall Study
COMPLETED
|
48
|
49
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Natures Tears
n=49 Participants
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.
|
Num Vapocoolant Spray
n=49 Participants
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.
|
Total
n=98 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
28.9 Years
STANDARD_DEVIATION 6.7 • n=49 Participants
|
29.7 Years
STANDARD_DEVIATION 6.1 • n=49 Participants
|
29.3 Years
STANDARD_DEVIATION 6.4 • n=98 Participants
|
|
Sex/Gender, Customized
Female
|
49 Participants
n=49 Participants
|
49 Participants
n=49 Participants
|
98 Participants
n=98 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Gestational age
|
62.6 days
STANDARD_DEVIATION 18.8 • n=49 Participants
|
60.2 days
STANDARD_DEVIATION 16.6 • n=49 Participants
|
61.4 days
STANDARD_DEVIATION 17.3 • n=98 Participants
|
|
Parity
|
33 Participants
n=49 Participants
|
31 Participants
n=49 Participants
|
64 Participants
n=98 Participants
|
|
History of vaginal deliveries (1 or more)
|
27 Participants
n=49 Participants
|
27 Participants
n=49 Participants
|
54 Participants
n=98 Participants
|
|
History of cesarean section (1 or more)
|
8 Participants
n=49 Participants
|
10 Participants
n=49 Participants
|
18 Participants
n=98 Participants
|
|
History of moderate or severe menstrual cramps
|
15 Participants
n=49 Participants
|
19 Participants
n=49 Participants
|
34 Participants
n=98 Participants
|
|
Prior gynecologic procedures
|
20 Participants
n=49 Participants
|
29 Participants
n=49 Participants
|
49 Participants
n=98 Participants
|
|
Anxiety
|
14 Participants
n=49 Participants
|
18 Participants
n=49 Participants
|
32 Participants
n=98 Participants
|
|
Depression
|
9 Participants
n=49 Participants
|
8 Participants
n=49 Participants
|
17 Participants
n=98 Participants
|
|
Level of provider
Intern
|
8 Participants
n=49 Participants
|
10 Participants
n=49 Participants
|
18 Participants
n=98 Participants
|
|
Level of provider
resident
|
1 Participants
n=49 Participants
|
5 Participants
n=49 Participants
|
6 Participants
n=98 Participants
|
|
Level of provider
fellow
|
29 Participants
n=49 Participants
|
30 Participants
n=49 Participants
|
59 Participants
n=98 Participants
|
|
Level of provider
attending
|
11 Participants
n=49 Participants
|
4 Participants
n=49 Participants
|
15 Participants
n=98 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Natures Tears
n=48 Participants
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.
|
Num Vapocoolant Spray
n=49 Participants
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.
|
|---|---|---|
|
Pain With Paracervical Block
|
27 units on a scale
Interval 10.0 to 49.0
|
20 units on a scale
Interval 5.0 to 49.0
|
SECONDARY outcome
Timeframe: Immediately after their gynecologic procedure (0 minutes after procedure completed)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.
Outcome measures
| Measure |
Natures Tears
n=48 Participants
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.
|
Num Vapocoolant Spray
n=49 Participants
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.
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|---|---|---|
|
Patient Satisfaction With Procedure
Satisfaction w procedure
|
91.5 units on a scale
Interval 66.0 to 99.0
|
94 units on a scale
Interval 74.0 to 99.0
|
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Patient Satisfaction With Procedure
Satisfaction with pain control during procedure
|
82 units on a scale
Interval 48.8 to 98.0
|
75 units on a scale
Interval 53.0 to 98.5
|
SECONDARY outcome
Timeframe: Within 5 minutes after patient procedureImmediately 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.
Outcome measures
| Measure |
Natures Tears
n=48 Participants
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.
|
Num Vapocoolant Spray
n=49 Participants
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.
|
|---|---|---|
|
Provider Ease of Use
|
0 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline pain (immediately before procedure), after tenaculum (0 minutes after tenaculum placed), and 5 minutes after procedureThe 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.
Outcome measures
| Measure |
Natures Tears
n=48 Participants
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.
|
Num Vapocoolant Spray
n=49 Participants
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.
|
|---|---|---|
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Other Pain Points During Gynecology Procedure
Baseline Pain
|
1 units on a scale
Interval 0.0 to 3.75
|
0 units on a scale
Interval 0.0 to 4.0
|
|
Other Pain Points During Gynecology Procedure
Tenaculum
|
17 units on a scale
Interval 2.0 to 33.0
|
9 units on a scale
Interval 1.5 to 24.0
|
|
Other Pain Points During Gynecology Procedure
Pain immediately after procedure
|
53 units on a scale
Interval 20.0 to 73.5
|
56 units on a scale
Interval 27.0 to 72.0
|
|
Other Pain Points During Gynecology Procedure
Pain 5 minutes post op
|
23 units on a scale
Interval 5.5 to 46.5
|
23 units on a scale
Interval 5.5 to 46.5
|
SECONDARY outcome
Timeframe: Immediately after enrollment - before procedureThe 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.
Outcome measures
| Measure |
Natures Tears
n=48 Participants
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.
|
Num Vapocoolant Spray
n=49 Participants
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.
|
|---|---|---|
|
Pre Procedure Anxiety
|
59 units on a scale
Interval 35.0 to 79.8
|
48 units on a scale
Interval 21.0 to 57.0
|
Adverse Events
Natures Tears
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Num Vapocoolant Spray
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Natures Tears
n=48 participants at risk
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.
|
Num Vapocoolant Spray
n=49 participants at risk
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.
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|---|---|---|
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Reproductive system and breast disorders
Vaginal itching
|
0.00%
0/48 • 1 week postprocedure
Adverse events were captured in a few ways: 1. Patients were called 2 days after procedure to see if they had any concerning side effect/symptoms. 2. If any patients called post op with any concerning side effects/symptoms. All patients were given our clinic line, our 24 hour line to a doctor on call on our team and the research line. 3. I any patients presented to the ED for complications from procedure.
|
2.0%
1/49 • Number of events 1 • 1 week postprocedure
Adverse events were captured in a few ways: 1. Patients were called 2 days after procedure to see if they had any concerning side effect/symptoms. 2. If any patients called post op with any concerning side effects/symptoms. All patients were given our clinic line, our 24 hour line to a doctor on call on our team and the research line. 3. I any patients presented to the ED for complications from procedure.
|
|
Reproductive system and breast disorders
Bleeding
|
0.00%
0/48 • 1 week postprocedure
Adverse events were captured in a few ways: 1. Patients were called 2 days after procedure to see if they had any concerning side effect/symptoms. 2. If any patients called post op with any concerning side effects/symptoms. All patients were given our clinic line, our 24 hour line to a doctor on call on our team and the research line. 3. I any patients presented to the ED for complications from procedure.
|
2.0%
1/49 • Number of events 1 • 1 week postprocedure
Adverse events were captured in a few ways: 1. Patients were called 2 days after procedure to see if they had any concerning side effect/symptoms. 2. If any patients called post op with any concerning side effects/symptoms. All patients were given our clinic line, our 24 hour line to a doctor on call on our team and the research line. 3. I any patients presented to the ED for complications from procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place