Paracervical BlockPhase 2NCT00811187
Paracervical Block During Office Hysteroscopy
A Phase 2 study testing Lidocaine paracervical block and Normal Saline in people with Paracervical Block, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of paracervical block for pain relief in office hysteroscopy - particularly with the placement of the Essure device. Subjects will be randomized to receive either paracervical block or saline, and will have pain assessments performed throughout the procedure. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Paracervical Block
- What is being tested?
- Lidocaine paracervical block and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Sep 2008
- Phase
- Phase 2
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women eligible and scheduled for office hysteroscopic placement of essure devices
Who cannot join
- Planned secondary procedures
- Lidocaine allergy
- Repeat procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Centennial Women's Center / Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Paracervical Block During Office Hysteroscopy: A Randomized Double Blind Placebo-controlled Trial
The purpose of this study is to determine the effectiveness of paracervical block for pain relief in office hysteroscopy - particularly with the placement of the Essure device. Subjects will be randomized to receive either paracervical block or saline, and will have pain assessments performed throughout the procedure. Subjects and physicians will be blinded to group assignments.
- Conditions
- Paracervical Block
- Being tested
- Lidocaine paracervical block, Normal Saline
- Keywords
- Hysteroscopy, Pain medication, Lidocaine, Office Procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine paracervical blockDrug
5cc 1% lidocaine injection in each paracervical region
Normal SalineDrug
5cc Normal Saline injection in each paracervical region
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine paracervical block | Experimental | 5cc 1% lidocaine injection in each paracervical region Receives: Drug: Lidocaine paracervical block |
| Saline placebo injection | Placebo comparator | 5cc Normal Saline injection in each paracervical region Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure.
This used a visual analog scale from 0 (minimum) to 10 (maximum) that was measured as centimeters. A higher score would indicate more pain, therefore, a worse outcome. Pain was assessed at each step that could potentially elicit pain, specifically when there was direct physical manipulation.
Measured: During Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startMar 2007
- Primary completionMar 2008
- Study completionSep 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paracervical BlockStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Chudnoff, MD, Principal investigator, Montefiore Medical Center/Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811187
- Sponsor's protocol ID
- 06-09-395
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2008
- Last updated
- 11 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Publications
Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):26-34. doi: 10.1097/AOG.0b013e3181c51ace.
PubMed 20027030
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracervical Block During Office Hysteroscopy: A Randomized Double Blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00811187
- Acronym / sponsor ID
- 06-09-395
- Conditions
- Paracervical Block
- Keywords
- Hysteroscopy, Pain medication, Lidocaine, Office Procedures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Posted 11 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of paracervical block for pain relief in office hysteroscopy - particularly with the placement of the Essure device. Subjects will be randomized to receive either paracervical block or saline, and will have pain assessments performed throughout the procedure. Subjects and physicians will be blinded to group assignments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine paracervical block | Experimental | Drug: Lidocaine paracervical block5cc 1% lidocaine injection in each paracervical region |
| Saline placebo injection | Placebo comparator | Drug: Normal Saline5cc Normal Saline injection in each paracervical region |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women eligible and scheduled for office hysteroscopic placement of essure devices
Key exclusion criteria (3 listed)
- Planned secondary procedures
- Lidocaine allergy
- Repeat procedures
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 paracervical block5cc 1% lidocaine injection in each paracervical region | Drug | Lidocaine paracervical block |
| Normal Saline5cc Normal Saline injection in each paracervical region | Drug | Saline placebo injection |
Primary outcome
Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure.
Time frame: During Procedure
This used a visual analog scale from 0 (minimum) to 10 (maximum) that was measured as centimeters. A higher score would indicate more pain, therefore, a worse outcome. Pain was assessed at each step that could potentially elicit pain, specifically when there was direct physical manipulation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20027030Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):26-34. doi: 10.1097/AOG.0b013e3181c51ace.
Related trials for Paracervical Block
Enrolling by invitationPhase 1
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Abnormal Uterine Bleeding, Analgesia
Not yet recruitingPhase 4
Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial
Hysterosalpingography-Related Pain
RecruitingPhase 4
Paracervical Block for Pain Reduction in Saline Infusion Sonograms
Pain During Saline Infusion Sonogram
RecruitingPhase 2
Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement
Pain Management, Abortion
Recruiting
Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension
Pelvic Organ Prolapse (POP), Postoperative Pain
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.
Scott Chudnoff, MD principal investigator
Montefiore Medical Center/Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine paracervical block and Normal Saline in people with Paracervical Block, run by Montefiore Medical Center 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 1 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 11 Dec 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2019). 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?
Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure. (time frame: During Procedure). 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 NCT00811187, which also lists 1 linked publication.
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 11 Dec 2019.