Pain With Paracervical Block, Pain With Gynecology Procedure, Pain
Conditions
Keywords
Pain with Paracervical Block, Pain with Gynecology Procedure, Num Vapocoolant Spray, Vapocoolant Spray, Vapocoolant
Brief summary
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.
Interventions
DEVICENum 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.
OTHERPlacebo
This is the placebo. This group will receive Natures tear normal saline spray.
Sponsors
Lakshmi Devi and Devraj Sharma Endowment
Queen's Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Research coordinators who will be collecting pain scales from patients will be blinded to intervention assignment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain With Paracervical Block | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Procedure | 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. |
| Provider Ease of Use | Within 5 minutes after patient procedure | 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. |
| Other Pain Points During Gynecology Procedure | Baseline pain (immediately before procedure), after tenaculum (0 minutes after tenaculum placed), and 5 minutes after 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. |
| Pre Procedure Anxiety | Immediately after enrollment - before procedure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| 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. | 49 |
| Total | 98 |
Baseline characteristics
| Characteristic | Natures Tears | Num Vapocoolant Spray | Total |
|---|---|---|---|
| Age, Continuous | 28.9 Years STANDARD_DEVIATION 6.7 | 29.7 Years STANDARD_DEVIATION 6.1 | 29.3 Years STANDARD_DEVIATION 6.4 |
| Anxiety | 14 Participants | 18 Participants | 32 Participants |
| Depression | 9 Participants | 8 Participants | 17 Participants |
| Gestational age | 62.6 days STANDARD_DEVIATION 18.8 | 60.2 days STANDARD_DEVIATION 16.6 | 61.4 days STANDARD_DEVIATION 17.3 |
| History of cesarean section (1 or more) | 8 Participants | 10 Participants | 18 Participants |
| History of moderate or severe menstrual cramps | 15 Participants | 19 Participants | 34 Participants |
| History of vaginal deliveries (1 or more) | 27 Participants | 27 Participants | 54 Participants |
| Level of provider attending | 11 Participants | 4 Participants | 15 Participants |
| Level of provider fellow | 29 Participants | 30 Participants | 59 Participants |
| Level of provider Intern | 8 Participants | 10 Participants | 18 Participants |
| Level of provider resident | 1 Participants | 5 Participants | 6 Participants |
| Parity | 33 Participants | 31 Participants | 64 Participants |
| Prior gynecologic procedures | 20 Participants | 29 Participants | 49 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex/Gender, Customized Female | 49 Participants | 49 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 49 |
| other Total, other adverse events | 0 / 48 | 2 / 49 |
| serious Total, serious adverse events | 0 / 48 | 0 / 49 |
Outcome results
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.
Time frame: Immediately after paracervical block (0 minutes after PCB completed)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Natures Tears | Pain With Paracervical Block | 27 units on a scale |
| Num Vapocoolant Spray | Pain With Paracervical Block | 20 units on a scale |
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.
Time frame: Baseline pain (immediately before procedure), after tenaculum (0 minutes after tenaculum placed), and 5 minutes after procedure
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Natures Tears | Other Pain Points During Gynecology Procedure | Baseline Pain | 1 units on a scale |
| Natures Tears | Other Pain Points During Gynecology Procedure | Tenaculum | 17 units on a scale |
| Natures Tears | Other Pain Points During Gynecology Procedure | Pain immediately after procedure | 53 units on a scale |
| Natures Tears | Other Pain Points During Gynecology Procedure | Pain 5 minutes post op | 23 units on a scale |
| Num Vapocoolant Spray | Other Pain Points During Gynecology Procedure | Pain 5 minutes post op | 23 units on a scale |
| Num Vapocoolant Spray | Other Pain Points During Gynecology Procedure | Baseline Pain | 0 units on a scale |
| Num Vapocoolant Spray | Other Pain Points During Gynecology Procedure | Pain immediately after procedure | 56 units on a scale |
| Num Vapocoolant Spray | Other Pain Points During Gynecology Procedure | Tenaculum | 9 units on a scale |
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.
Time frame: Immediately after their gynecologic procedure (0 minutes after procedure completed)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Natures Tears | Patient Satisfaction With Procedure | Satisfaction w procedure | 91.5 units on a scale |
| Natures Tears | Patient Satisfaction With Procedure | Satisfaction with pain control during procedure | 82 units on a scale |
| Num Vapocoolant Spray | Patient Satisfaction With Procedure | Satisfaction w procedure | 94 units on a scale |
| Num Vapocoolant Spray | Patient Satisfaction With Procedure | Satisfaction with pain control during procedure | 75 units on a scale |
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.
Time frame: Immediately after enrollment - before procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Natures Tears | Pre Procedure Anxiety | 59 units on a scale |
| Num Vapocoolant Spray | Pre Procedure Anxiety | 48 units on a scale |
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.
Time frame: Within 5 minutes after patient procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Natures Tears | Provider Ease of Use | 0 units on a scale |
| Num Vapocoolant Spray | Provider Ease of Use | 0 units on a scale |