PainPhase 4NCT03356145
12 Versus 20 mL PCB for D&E Cervical Prep
A Phase 4 study testing 12 mL paracervical block and 20 mL paracervical block in people with Pain, run by Stanford University at 1 site in United States.
Trial summary
More research is needed to investigate methods of pain control for cervical preparation for abortion procedures. Women report pain with paracervical block injection as well as with osmotic dilator placement. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- 12 mL paracervical block and 20 mL paracervical block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 15 Oct 2020
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women 18 and older
- Intrauterine pregnancy ≥16 weeks gestation
- English speaking competency
- Willing and able to sign consent forms
- Agree to comply with study procedures
Who cannot join
- Women less than 18 years of age
- IV conscious sedation
- Known allergy to study medication (lidocaine)
- Any women not meeting inclusion criteria above will be excluded from participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 12 Versus 20 mL Paracervical Block for Pain-Control During Cervical Preparation for Dilation and Evacuation: A Single-Blinded Randomized Controlled Trial
More research is needed to investigate methods of pain control for cervical preparation for abortion procedures. Women report pain with paracervical block injection as well as with osmotic dilator placement. This study seeks to compare a 12 mL, 2-site 1% plain lidocaine paracervical block for pain control during cervical preparation (osmotic dilator insertion) for Dilation and Evacuation (D\&E) to a 20 mL 1% lidocaine 2-site paracervical block.
Read the detailed description
This is a non-inferiority, single blinded, randomized controlled trial.This study will use a 2-site, 12 mL 1% plain lidocaine injection paracervical block (PCB) technique (2 mL for tenaculum placement, 10 mL for paracervical block) will provide non-inferior pain control compared to a previously established 2-site, 20 mL 1% lidocaine injection PCB (2 mL for tenaculum placement, 18 mL for paracervical block) when administered for dilation pain control during cervical preparation.
- Conditions
- Pain
- Being tested
- 12 mL paracervical block, 20 mL paracervical block
- Keywords
- paracervical block, abortion, dilation and evacuation, cervical preparation
- Medical subject headings
- Pain, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 mL paracervical blockDrug
Injection of 12 mL of lidocaine
20 mL paracervical blockDrug
Injection of 20 mL of lidocaine
| Study group | Role | What they receive |
|---|---|---|
| 12 mL arm | Experimental | Intervention:
* Syringe loaded with 12 mL of 1% lidocaine (120 mg); 22-gauge spinal needle
* 2 mL injected at the tenaculum site, either 6 or 12 o'clock superficially into the cervix
* The tenaculum is immediately placed at the previously injected site
* The remaining 10 mL are slowly injected into the cervicovaginal junction in two equal aliquots at 4 and 8 o'clock; the injection is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal)
* No wait time between injection and dilator insertion Receives: Drug: 12 mL paracervical block |
| 20 mL arm | Active comparator | Intervention:
* Syringe loaded with 20 mL of 1% lidocaine (120 mg); 22-gauge spinal needle
* 2 mL injected at the tenaculum site, either 6 or 12 o'clock superficially into the cervix
* The tenaculum is immediately placed at the previously injected site
* The remaining 18 mL are slowly injected into the cervicovaginal junction in two equal aliquots at 4 and 8 o'clock; the injection is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal)
* No wait time between injection and dilator insertion Receives: Drug: 20 mL paracervical block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Immediately Following Dilator Insertion
The primary objective is to determine pain perceived immediately following dilator insertion measured by Visual Analogue Scale (VAS) (0-100mm; 0 being no pain, 100 being worst pain imaginable).
Measured: Time of dilator insertion (less than 1 minute to assess pain)
Secondary outcomes (6)
Anticipated Pain Immediately Prior to Dilator Insertion
Pain measured by VAS (0-100mm; 0 being no pain, 100 being worst pain imaginable).
Measured: Up to 1 minute to complete survey
Patient Global Satisfaction Score
Global satisfaction (acceptability) of procedure reported by participant, measured by 0-100mm VAS; with anchors at 0 ("worse than expected"), 50 ("what I expected"), and 100 ("better than expected").
Measured: Up to 1 minute to complete survey
Total Procedure Time
Defined as time of speculum insertion
Measured: Up to 10 minutes
Physician-reported Ease of Insertion
Measured by VAS (0-100mm; 0 being "very easy", 100 being "very difficult").
Measured: Up to 1 minute to complete survey
Count of Participants With Procedural Complications
Measured: Up to 10 minutes
Count of Participants With Side Effects Related to Lidocaine Administration
Side effects were not necessarily considered to be adverse events by investigator.
Measured: Up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Jan 2017
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
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 PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two study arms via computer-generated block randomization using REDCap software.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356145
- Sponsor's protocol ID
- IRB-43789
- Status last verified
- Jan 2024
- First submitted
- 20 Nov 2017
- Last updated
- 23 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers.
Publications
Shaw KA, Lerma K, Hughes T, Hastings C, Fok WK, Blumenthal PD. A Comparison of Paracervical Block Volumes Before Osmotic Dilator Placement: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):443-448. doi: 10.1097/AOG.0000000000004485.
PubMed 34352829
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12 Versus 20 mL Paracervical Block for Pain-Control During Cervical Preparation for Dilation and Evacuation: A Single-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03356145
- Acronym / sponsor ID
- IRB-43789
- Conditions
- Pain
- Keywords
- paracervical block, abortion, dilation and evacuation, cervical preparation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Posted 19 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More research is needed to investigate methods of pain control for cervical preparation for abortion procedures. Women report pain with paracervical block injection as well as with osmotic dilator placement. This study seeks to compare a 12 mL, 2-site 1% plain lidocaine paracervical block for pain control during cervical preparation (osmotic dilator insertion) for Dilation and Evacuation (D\&E) to a 20 mL 1% lidocaine 2-site paracervical block.
Detailed description
This is a non-inferiority, single blinded, randomized controlled trial.This study will use a 2-site, 12 mL 1% plain lidocaine injection paracervical block (PCB) technique (2 mL for tenaculum placement, 10 mL for paracervical block) will provide non-inferior pain control compared to a previously established 2-site, 20 mL 1% lidocaine injection PCB (2 mL for tenaculum placement, 18 mL for paracervical block) when administered for dilation pain control during cervical preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two study arms via computer-generated block randomization using REDCap software.
| Arm | Type | Receives |
|---|---|---|
| 12 mL arm | Experimental | Drug: 12 mL paracervical blockIntervention: * Syringe loaded with 12 mL of 1% lidocaine (120 mg); 22-gauge spinal needle * 2 mL injected at the tenaculum site, either 6 or 12 o'clock superficially into the cervix * The tenaculum is immediately placed at the previously injected site * The remaining 10 mL are slowly injected into the cervicovaginal junction in two equal aliquots at 4 and 8 o'clock; the injection is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal) * No wait time between injection and dilator insertion |
| 20 mL arm | Active comparator | Drug: 20 mL paracervical blockIntervention: * Syringe loaded with 20 mL of 1% lidocaine (120 mg); 22-gauge spinal needle * 2 mL injected at the tenaculum site, either 6 or 12 o'clock superficially into the cervix * The tenaculum is immediately placed at the previously injected site * The remaining 18 mL are slowly injected into the cervicovaginal junction in two equal aliquots at 4 and 8 o'clock; the injection is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal) * No wait time between injection and dilator insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women 18 and older
- Intrauterine pregnancy ≥16 weeks gestation
- English speaking competency
- Willing and able to sign consent forms
- Agree to comply with study procedures
Key exclusion criteria (4 listed)
- Women less than 18 years of age
- IV conscious sedation
- Known allergy to study medication (lidocaine)
- Any women not meeting inclusion criteria above will be excluded from participation
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 |
|---|---|---|
| 12 mL paracervical blockInjection of 12 mL of lidocaine | Drug | 12 mL arm |
| 20 mL paracervical blockInjection of 20 mL of lidocaine | Drug | 20 mL arm |
Primary outcome
Pain Immediately Following Dilator Insertion
Time frame: Time of dilator insertion (less than 1 minute to assess pain)
The primary objective is to determine pain perceived immediately following dilator insertion measured by Visual Analogue Scale (VAS) (0-100mm; 0 being no pain, 100 being worst pain imaginable).
6 secondary outcomes
Anticipated Pain Immediately Prior to Dilator Insertion
Time frame: Up to 1 minute to complete survey
Patient Global Satisfaction Score
Time frame: Up to 1 minute to complete survey
Total Procedure Time
Time frame: Up to 10 minutes
Physician-reported Ease of Insertion
Time frame: Up to 1 minute to complete survey
Count of Participants With Procedural Complications
Time frame: Up to 10 minutes
Count of Participants With Side Effects Related to Lidocaine Administration
Time frame: Up to 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34352829Shaw KA, Lerma K, Hughes T, Hastings C, Fok WK, Blumenthal PD. A Comparison of Paracervical Block Volumes Before Osmotic Dilator Placement: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):443-448. doi: 10.1097/AOG.0000000000004485.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 12 mL paracervical block and 20 mL paracervical block in people with Pain, run by Stanford University 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 5 inclusion and 4 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 23 Jan 2024. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 19 Oct 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?
Pain Immediately Following Dilator Insertion (time frame: Time of dilator insertion (less than 1 minute to assess pain)). 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 NCT03356145, 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 23 Jan 2024.