PregnancyNCT00583011
Local Anesthesia and Pain Perception During an Amniocentesis
A study testing Local Anesthesia in people with Pregnancy, run by University of Oklahoma at 1 site in United States.
Trial summary
This study is been designed to answer the question of whether local anesthesia (1% lidocaine) decreases the perception of pain associated with amniocentesis in a randomized double blind placebo controlled manner. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Local Anesthesia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to May 2011
- Phase
- Interventional
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancies
- Signed consent to participate in the trial
- Women between the ages of 18 and 45 years
- Gestational ages 15 - 24 weeks
Who cannot join
- Multiple gestation
- Refusal to participate in the trial
- Known hypersensitivity to lidocaine
- Amniocentesis during this pregnancy
- Amnioinfusion/amnioreduction where the procedure is likely to be prolonged
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Local Anesthesia and Pain Perception During Amniocentesis: A Randomized Placebo-controlled Trial
This study is been designed to answer the question of whether local anesthesia (1% lidocaine) decreases the perception of pain associated with amniocentesis in a randomized double blind placebo controlled manner. Our objective is to determine the effect of local anesthesia on the maternal pain perception from an amniocentesis.
Read the detailed description
Women meeting criteria for project and agreeing to treatment will be randomized into either the 1% Lidocaine or placebo(normal saline) group. The initial injection of either 1% lidocaine or placebo (normal saline) will be administered 2 minutes prior to the amniocentesis procedure. 2cc of 1% lidocaine or placebo (normal saline) will be initially administered as an intradermal "wheal", followed by a deeper infiltration of the 1% lidocaine or placebo (normal saline) to the depth of the peritoneum. All procedures will be performed by either the Maternal-Fetal medicine (MFM) or the reproductive geneticist utilizing continuous ultrasound guidance under sterile conditions. Each woman will be asked to rate their pain perception immediately after the procedure on two pain scales.
- Conditions
- Pregnancy
- Being tested
- Local Anesthesia, Placebo Group
- Keywords
- Amniocentesis, Genetic amniocentesis, Fetal lung maturity, Pain control, Pregnancy, High risk pregnancy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local AnesthesiaDrug
Also called Amniocentesis
Local anesthesia: 2 cc of 1% Lidocaine
Placebo GroupDrug
Also called Amniocentesis
Placebo Group: 2cc Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Local Anesthesia | Experimental | Local anesthesia group. 2cc of 1% lidocaine with epinephrine administered 2 minutes before amniocentesis, using a 21 gauge needle initially as an intradermal wheal followed by a deeper infiltration of 2cc of 1% lidocaine to the depth of the peritoneum. Receives: Drug: Local Anesthesia |
| Placebo-Normal saline | Placebo comparator | Placebo normal saline group. 2cc of normal saline epinephrine administered 2 minutes before amniocentesis, using a 21 gauge needle initially as an intradermal wheal followed by a deeper infiltration of 2cc of normal saline to the depth of the peritoneum. Receives: Drug: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS)
Visual Analogue Scale (Perpendicular line is drawn at the point that represents pain on a 0-100mm scale, with lower number meaning less pain and the higher number meaning more pain)
Measured: Immediately following amniocentesis procedure
Secondary outcomes (1)
Intensity of Perceived Maternal Pain as Measured by the 101 Point Numerical Rating Scale (NRS-101)
101 Point Numerical Rating Scale (NRS-101) (Choose a number that best described pain from 0 to 100 with 0 being least amount of pain and 100 being the worst pain)
Measured: Immediately following amniocentesis procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionMay 2011
- Study completionMay 2011
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.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Elimian, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583011
- Sponsor's protocol ID
- AmniocentesisPain
- Status last verified
- Jan 2021
- First submitted
- 19 Dec 2007
- Last updated
- 3 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anesthesia and Pain Perception During Amniocentesis: A Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00583011
- Acronym / sponsor ID
- AmniocentesisPain
- Conditions
- Pregnancy
- Keywords
- Amniocentesis, Genetic amniocentesis, Fetal lung maturity, Pain control, Pregnancy, High risk pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Posted 3 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is been designed to answer the question of whether local anesthesia (1% lidocaine) decreases the perception of pain associated with amniocentesis in a randomized double blind placebo controlled manner. Our objective is to determine the effect of local anesthesia on the maternal pain perception from an amniocentesis.
Detailed description
Women meeting criteria for project and agreeing to treatment will be randomized into either the 1% Lidocaine or placebo(normal saline) group. The initial injection of either 1% lidocaine or placebo (normal saline) will be administered 2 minutes prior to the amniocentesis procedure. 2cc of 1% lidocaine or placebo (normal saline) will be initially administered as an intradermal "wheal", followed by a deeper infiltration of the 1% lidocaine or placebo (normal saline) to the depth of the peritoneum. All procedures will be performed by either the Maternal-Fetal medicine (MFM) or the reproductive geneticist utilizing continuous ultrasound guidance under sterile conditions. Each woman will be asked to rate their pain perception immediately after the procedure on two pain scales.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Anesthesia | Experimental | Drug: Local AnesthesiaLocal anesthesia group. 2cc of 1% lidocaine with epinephrine administered 2 minutes before amniocentesis, using a 21 gauge needle initially as an intradermal wheal followed by a deeper infiltration of 2cc of 1% lidocaine to the depth of the peritoneum. |
| Placebo-Normal saline | Placebo comparator | Drug: Placebo GroupPlacebo normal saline group. 2cc of normal saline epinephrine administered 2 minutes before amniocentesis, using a 21 gauge needle initially as an intradermal wheal followed by a deeper infiltration of 2cc of normal saline to the depth of the peritoneum. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Singleton pregnancies
- Signed consent to participate in the trial
- Women between the ages of 18 and 45 years
- Gestational ages 15 - 24 weeks
Key exclusion criteria (5 listed)
- Multiple gestation
- Refusal to participate in the trial
- Known hypersensitivity to lidocaine
- Amniocentesis during this pregnancy
- Amnioinfusion/amnioreduction where the procedure is likely to be prolonged
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 |
|---|---|---|
| Local AnesthesiaAlso: AmniocentesisLocal anesthesia: 2 cc of 1% Lidocaine | Drug | Local Anesthesia |
| Placebo GroupAlso: AmniocentesisPlacebo Group: 2cc Normal Saline | Drug | Placebo-Normal saline |
Primary outcome
Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS)
Time frame: Immediately following amniocentesis procedure
Visual Analogue Scale (Perpendicular line is drawn at the point that represents pain on a 0-100mm scale, with lower number meaning less pain and the higher number meaning more pain)
1 secondary outcome
Intensity of Perceived Maternal Pain as Measured by the 101 Point Numerical Rating Scale (NRS-101)
Time frame: Immediately following amniocentesis procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrew Elimian, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Anesthesia in people with Pregnancy, run by University of Oklahoma 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 5 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 3 Feb 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2021). 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?
Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS) (time frame: Immediately following amniocentesis procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2021.