Chorionic Villi SamplingEarly Phase 1NCT03140293
Pain Perception During Chorionic Villus Sampling
A Early Phase 1 study testing Lidocaine injection and Gebauer Ethyl Chloride Spray in people with Chorionic Villi Sampling, run by Angela Bianco at 1 site in United States.
Trial summary
Chorionic villous sampling is a frequent procedure used for antenatal genetic testing. This procedure is associated with anxiety and fear of pain that can be expected during the procedure, often prejudicing patients against this definitive antenatal testing. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chorionic Villi Sampling
- What is being tested?
- Lidocaine injection and Gebauer Ethyl Chloride Spray
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 23 May 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- <13 week gestation
- Singleton gestations undergoing CVS
Who cannot join
- Multiple gestations
- More than one attempt of needle insertion
- Allergy or hypersensitivity to local anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Randomized Trial to Determine if Local Anesthesia Decreases Pain Perception in Women Undergoing Chorionic Villus Sampling
Chorionic villous sampling is a frequent procedure used for antenatal genetic testing. This procedure is associated with anxiety and fear of pain that can be expected during the procedure, often prejudicing patients against this definitive antenatal testing. It is important to determine if different approaches to pain and anxiety reduction are effective. Currently there is no randomized study to evaluate the efficacy of analgesia for pain reduction during chorionic villous sampling. Multiple studies have been published suggesting that analgesia during the similar procedure of amniocentesis does not significantly reduce pain scores.
Read the detailed description
Chorionic villous sampling (CVS) is a frequent procedure used for antenatal genetic testing. This procedure is associated with anxiety and fear of pain that can be expected during the procedure, often prejudicing patients against this definitive antenatal testing. It is important to determine if different approaches to pain and anxiety reduction are effective. Previous studies have not shown that local anesthesia affects pain experience during amniocentesis (1-5). There are no randomized studies evaluating interventions for pain reduction during chorionic villous sampling which constitutes an important evidence gap.
The study will be offered to women at <13 weeks gestation, with a singleton fetus who are seen at Mount Sinai Medical Center for chorionic villous sampling. The eligible women will be randomized to one of two groups: use of analgesia using injectable lidocaine or ethyl chloride topical anesthetic spray. This study intends to show that local anesthesia during chorionic villous sampling will not decrease the perception of pain in patients undergoing this procedure.
This trial is trying to determine perception of pain based on use of injectable lidocaine or ethyl chloride anesthetic spray; it is noted that the form of anesthesia may be a factor in perception of pain. The investigators do not know if there is a difference in perception for topical or injectable. If the perceived pain is comparable in topical and injectable, this trial could conclude that both are viable options, and while both present minimal risk to patients, topical is less invasive.
- Conditions
- Chorionic Villi Sampling
- Being tested
- Lidocaine injection, Gebauer Ethyl Chloride Spray
- Keywords
- Chorionic villus sampling, Pain, Anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine injectionDrug
Injectable anesthesia is 1-2mL of 2% lidocaine via a 22 gage needle, given at the anticipated site of CVS needle puncture immediately before procedure.
Gebauer Ethyl Chloride SprayDrug
Gebauer Ethyl Chloride Spray is a topical anesthetic spray which is sprayed continuously for 3-7 seconds from a distance of 3-9 inches at the site where the chorionic villus sampling is expected to take place.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Injection | Active comparator | Injection of lidocaine which is given prior to chorionic villus sampling Receives: Drug: Lidocaine injection |
| Gebauer Ethyl Chloride Spray | Experimental | Topical anesthesia will be Gebauer Ethyl Chloride sprayed continuously from 3 - 7 seconds from a distance of 3-9 inches until the skin turns white (not frosting the skin) as per Gebauer package insert instructions. Receives: Drug: Gebauer Ethyl Chloride Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Pain perception scores VAS ()
Procedure pain perception score as measured by the visual analog scale. By means of analysis of the receiver operating characteristic curves on a 100mm VAS: no pain 0-2 mm, mild pain 2-17 mm, moderate pain 17-47 mm, severe pain 47-77 mm, very severe pain 77-96 mm, most severe pain imaginable 96-100 mm
Measured: day 1
Verbal Rating Scale (VRS)
Procedure pain perception score as measured by the Verbal Rating Scale. 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain, 4=very severe pain, 5=most severe pain imaginable
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study startSep 2016
- Primary completion23 May 2017
- Study completion23 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chorionic Villi SamplingStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angela Bianco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Angela Bianco, Icahn School of Medicine at Mount Sinai
- Investigators
- Patricia Rekawek, M.D., Principal investigator, Icahn School of Medicine at Mount SinaiAngela Bianco, M.D., Study director, Ichan School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140293
- Sponsor's protocol ID
- GCO 14-1425
- Status last verified
- Oct 2017
- First submitted
- 28 Mar 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8604867Csaba A, Bush MC, Saphier C. How painful are amniocentesis and chorionic villus sampling? Prenat Diagn. 2006 Jan;26(1):35-8. doi: 10.1002/pd.1323.
PubMed 16378331Mujezinovic F, Alfirevic Z. Analgesia for amniocentesis or chorionic villus sampling. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD008580. doi: 10.1002/14651858.CD008580.pub2.
PubMed 22071854Gordon MC, Ventura-Braswell A, Higby K, Ward JA. Does local anesthesia decrease pain perception in women undergoing amniocentesis? Am J Obstet Gynecol. 2007 Jan;196(1):55.e1-4. doi: 10.1016/j.ajog.2006.08.025.
PubMed 17240233Van Schoubroeck D, Verhaeghe J. Does local anesthesia at mid-trimester amniocentesis decrease pain experience? A randomized trial in 220 patients. Ultrasound Obstet Gynecol. 2000 Nov;16(6):536-8. doi: 10.1046/j.1469-0705.2000.00240.x.
PubMed 11169347Rekawek P, Stone JL, Robles B, Connolly KA, Bigelow CA, Tudela F, Bianco AT. Pain perception during transabdominal chorionic villus sampling: a randomized trial comparing topical ethyl chloride anesthetic spray and lidocaine injection. J Matern Fetal Neonatal Med. 2021 Feb;34(3):339-345. doi: 10.1080/14767058.2019.1607288. Epub 2019 Apr 25.
PubMed 30983457
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Determine if Local Anesthesia Decreases Pain Perception in Women Undergoing Chorionic Villus Sampling
- ClinicalTrials.gov ID
- NCT03140293
- Acronym / sponsor ID
- GCO 14-1425
- Conditions
- Chorionic Villi Sampling
- Keywords
- Chorionic villus sampling, Pain, Anxiety
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Angela BiancoUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chorionic villous sampling is a frequent procedure used for antenatal genetic testing. This procedure is associated with anxiety and fear of pain that can be expected during the procedure, often prejudicing patients against this definitive antenatal testing. It is important to determine if different approaches to pain and anxiety reduction are effective. Currently there is no randomized study to evaluate the efficacy of analgesia for pain reduction during chorionic villous sampling. Multiple studies have been published suggesting that analgesia during the similar procedure of amniocentesis does not significantly reduce pain scores.
Detailed description
Chorionic villous sampling (CVS) is a frequent procedure used for antenatal genetic testing. This procedure is associated with anxiety and fear of pain that can be expected during the procedure, often prejudicing patients against this definitive antenatal testing. It is important to determine if different approaches to pain and anxiety reduction are effective. Previous studies have not shown that local anesthesia affects pain experience during amniocentesis (1-5). There are no randomized studies evaluating interventions for pain reduction during chorionic villous sampling which constitutes an important evidence gap.
The study will be offered to women at <13 weeks gestation, with a singleton fetus who are seen at Mount Sinai Medical Center for chorionic villous sampling. The eligible women will be randomized to one of two groups: use of analgesia using injectable lidocaine or ethyl chloride topical anesthetic spray. This study intends to show that local anesthesia during chorionic villous sampling will not decrease the perception of pain in patients undergoing this procedure.
This trial is trying to determine perception of pain based on use of injectable lidocaine or ethyl chloride anesthetic spray; it is noted that the form of anesthesia may be a factor in perception of pain. The investigators do not know if there is a difference in perception for topical or injectable. If the perceived pain is comparable in topical and injectable, this trial could conclude that both are viable options, and while both present minimal risk to patients, topical is less invasive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Injection | Active comparator | Drug: Lidocaine injectionInjection of lidocaine which is given prior to chorionic villus sampling |
| Gebauer Ethyl Chloride Spray | Experimental | Drug: Gebauer Ethyl Chloride SprayTopical anesthesia will be Gebauer Ethyl Chloride sprayed continuously from 3 - 7 seconds from a distance of 3-9 inches until the skin turns white (not frosting the skin) as per Gebauer package insert instructions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- <13 week gestation
- Singleton gestations undergoing CVS
Key exclusion criteria (3 listed)
- Multiple gestations
- More than one attempt of needle insertion
- Allergy or hypersensitivity to local anesthesia
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 |
|---|---|---|
| Lidocaine injectionInjectable anesthesia is 1-2mL of 2% lidocaine via a 22 gage needle, given at the anticipated site of CVS needle puncture immediately before procedure. | Drug | Lidocaine Injection |
| Gebauer Ethyl Chloride SprayGebauer Ethyl Chloride Spray is a topical anesthetic spray which is sprayed continuously for 3-7 seconds from a distance of 3-9 inches at the site where the chorionic villus sampling is expected to take place. | Drug | Gebauer Ethyl Chloride Spray |
Primary outcome
Visual Analog Scale (VAS) Pain perception scores VAS ()
Time frame: day 1
Procedure pain perception score as measured by the visual analog scale. By means of analysis of the receiver operating characteristic curves on a 100mm VAS: no pain 0-2 mm, mild pain 2-17 mm, moderate pain 17-47 mm, severe pain 47-77 mm, very severe pain 77-96 mm, most severe pain imaginable 96-100 mm
Verbal Rating Scale (VRS)
Time frame: day 1
Procedure pain perception score as measured by the Verbal Rating Scale. 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain, 4=very severe pain, 5=most severe pain imaginable
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Background: PubMed 8604867Todd 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.
- Background: PubMed 16378331Csaba A, Bush MC, Saphier C. How painful are amniocentesis and chorionic villus sampling? Prenat Diagn. 2006 Jan;26(1):35-8. doi: 10.1002/pd.1323.
- Background: PubMed 22071854Mujezinovic F, Alfirevic Z. Analgesia for amniocentesis or chorionic villus sampling. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD008580. doi: 10.1002/14651858.CD008580.pub2.
- Background: PubMed 17240233Gordon MC, Ventura-Braswell A, Higby K, Ward JA. Does local anesthesia decrease pain perception in women undergoing amniocentesis? Am J Obstet Gynecol. 2007 Jan;196(1):55.e1-4. doi: 10.1016/j.ajog.2006.08.025.
- Background: PubMed 11169347Van Schoubroeck D, Verhaeghe J. Does local anesthesia at mid-trimester amniocentesis decrease pain experience? A randomized trial in 220 patients. Ultrasound Obstet Gynecol. 2000 Nov;16(6):536-8. doi: 10.1046/j.1469-0705.2000.00240.x.
- Derived from this study: PubMed 30983457Rekawek P, Stone JL, Robles B, Connolly KA, Bigelow CA, Tudela F, Bianco AT. Pain perception during transabdominal chorionic villus sampling: a randomized trial comparing topical ethyl chloride anesthetic spray and lidocaine injection. J Matern Fetal Neonatal Med. 2021 Feb;34(3):339-345. doi: 10.1080/14767058.2019.1607288. Epub 2019 Apr 25.
- Individual participant dataSharing planned: No
Related trials for Chorionic Villi Sampling
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Effect of Video -Based vs Standard ınformation on Maternal Anxiety and Procedure Decision in Pregnant Woman Offered Amniocentesis or Cvs
Maternal Anxiety, Prenatal Diagnosis
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.
Patricia Rekawek, M.D. principal investigator
Icahn School of Medicine at Mount Sinai
Angela Bianco, M.D. study director
Ichan School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lidocaine injection and Gebauer Ethyl Chloride Spray in people with Chorionic Villi Sampling, run by Angela Bianco 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 2 inclusion and 3 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 Oct 2017. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog Scale (VAS) Pain perception scores VAS () (time frame: day 1). The study lists 2 primary outcomes in all. 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 NCT03140293, which also lists 6 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 Oct 2017.