ContraceptionPhase 2PRICENCT06532162
The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment
A Phase 2 study testing 1% Lidocaine Paracervical Block and Normal Saline Paracervical Injection in people with Contraception, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Intrauterine devices (IUDs) are a highly effective form of reversible contraception with a less than 1% failure rate. They can be easily placed in the office and require little maintenance care. However, despite their benefits, pain during insertion remains a barrier for patient uptake. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraception
- What is being tested?
- 1% Lidocaine Paracervical Block and Normal Saline Paracervical Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jun 2022to 16 Aug 2024
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any participant presenting for an IUD placement, either for contraception or treatment of abnormal uterine bleeding or to regulate menstrual periods
- All IUDs (copper, hormonal) eligible
- All parities of patients are eligible
Who cannot join
- Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours
- Confirmed pregnancy
- Any diagnosed chronic pain conditions (fibromyalgia, vaginismus, interstitial cystitis)
- Misoprostol administration within 24 hours of enrollment
- Known contraindications to IUD placement
- Contraindication to lidocaine
- IUD exchange
- Previous unsuccessful attempt for IUD by the same practitioner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment. a Double-blind, Triple Arm, Randomized Controlled Trial of 1% Lidocaine Paracervical Block for IUD Insertion
Intrauterine devices (IUDs) are a highly effective form of reversible contraception with a less than 1% failure rate. They can be easily placed in the office and require little maintenance care. However, despite their benefits, pain during insertion remains a barrier for patient uptake. Currently there is no standard of care for pain management during IUD insertion. The aim of this study is to determine whether local anesthetic, in the form of injecting 1 percent lidocaine into the cervicovaginal junction, reduces pain during insertion. Participants will be randomly assigned to receive 1 percent lidocaine, placebo, or no injection. All patients presenting for IUD placement, regardless of indication, will be offered participation in the study. Following IUD placement, patients will be asked to rate their pain at key "pain points" during the procedure as the primary outcome. Other outcomes collected will include provider-related complications, length of time to place IUD, and overall patient and provider satisfaction.
- Conditions
- Contraception
- Being tested
- 1% Lidocaine Paracervical Block, Normal Saline Paracervical Injection
- Keywords
- Contraception, Intrauterine device, Paracervical block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Lidocaine Paracervical BlockDrug
A 22-gauge spinal needle will be loaded with 10 mL of 1% lidocaine with epinephrine.
The injection will be instilled slowly over 60 seconds into the cervicovaginal junction in two equal areas at 2 and 10 o'clock. The injection is continuous from superficial to deep (3 cm).
Normal Saline Paracervical InjectionDrug
A 22-gauge spinal needle will be loaded with 10 mL of normal saline. The injection will be instilled slowly over 60 seconds into the cervicovaginal junction in two equal areas at 2 and 10 o'clock. The injection is continuous from superficial to deep (3 cm).
| Study group | Role | What they receive |
|---|---|---|
| 1% Lidocaine Paracervical Block | Experimental | A 22-gauge spinal needle will be loaded with 10 mL of 1% lidocaine with epinephrine.
The injection will be instilled slowly over 60 seconds into the cervicovaginal junction in two equal areas at 2 and 10 o'clock. The injection is continuous from superficial to deep (3 cm). Receives: Drug: 1% Lidocaine Paracervical Block |
| Normal Saline Paracervical Injection | Sham comparator | A 22-gauge spinal needle will be loaded with 10 mL of normal saline. The injection will be instilled slowly over 60 seconds into the cervicovaginal junction in two equal areas at 2 and 10 o'clock. The injection is continuous from superficial to deep (3 cm). Receives: Drug: Normal Saline Paracervical Injection |
| Capped Needle Control | No intervention | A capped needle will gently be tapped on the cervicovaginal junction at two areas at 2 and 10 o'clock. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Pain Score
Patient-reported overall pain score on the 100 mm Visual Analogus Scale (VAS). A score of 0 mm is the minimum, 100 mm is the maximum, with higher scores indicating more pain (i.e. worse outcome).
Measured: Immediately following the procedure
Secondary outcomes (6)
Pain at specific pain points
Patient-reported pain score at specific pain points during the procedure, on the 100 mm Visual Analogus Scale (VAS). A score of 0 mm is the minimum, 100 mm is the maximum, with higher scores indicating more pain (i.e. worse outcome).
Measured: Baseline, after injection or placebo, tenaculum placement, uterine sounding, IUD insertion, 1 minute post-procedure
Immediate complications following the procedure (i.e. vasovagal response, dizziness, local anesthetic toxicity syndrome)
Provider reported based on events during the procedure
Measured: Immediately following the procedure
Length of time for analgesia
Stopwatch
Measured: Immediately following administration of the intervention, placebo, or control
Length of time for IUD placement
Stopwatch
Measured: Immediately following the procedure
Patient satisfaction
Survey-related questions, based on Likert scale and yes/no answers
Measured: Immediately following the procedure
Difficulty of IUD placement
Provider reported on Likert scale
Measured: 1 is minimum (least diffiult) and 5 is maximum (most difficult). Higher scores are worse outcome as they are more difficult.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start30 Jun 2022
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study is a double-blind, triple arm, placebo-controlled randomized clinical trial. Participants will be recruited from Mount Sinai Hospital outpatient gynecology clinics. Recruitment, consent, randomization, procedure, and post-procedure survey will occur during the same visit. Each participant will be randomly assigned to one of three arms: 1. Intervention (10 cc 1% lidocaine paracervical block) 2. Placebo (10 cc paracervical injection of normal saline) 3. Control (gently tapping the cervicovaginal junction with a capped needle)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mara Sobel, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532162
- Sponsor's protocol ID
- PRICE Trial
- Acronym
- PRICE
- Status last verified
- Jan 2025
- First submitted
- 29 Jul 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment. a Double-blind, Triple Arm, Randomized Controlled Trial of 1% Lidocaine Paracervical Block for IUD Insertion
- ClinicalTrials.gov ID
- NCT06532162
- Acronym / sponsor ID
- PRICE / PRICE Trial
- Conditions
- Contraception
- Keywords
- Contraception, Intrauterine device, Paracervical block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 1 Aug 2024 (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.
Intrauterine devices (IUDs) are a highly effective form of reversible contraception with a less than 1% failure rate. They can be easily placed in the office and require little maintenance care. However, despite their benefits, pain during insertion remains a barrier for patient uptake. Currently there is no standard of care for pain management during IUD insertion. The aim of this study is to determine whether local anesthetic, in the form of injecting 1 percent lidocaine into the cervicovaginal junction, reduces pain during insertion. Participants will be randomly assigned to receive 1 percent lidocaine, placebo, or no injection. All patients presenting for IUD placement, regardless of indication, will be offered participation in the study. Following IUD placement, patients will be asked to rate their pain at key "pain points" during the procedure as the primary outcome. Other outcomes collected will include provider-related complications, length of time to place IUD, and overall patient and provider satisfaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The proposed study is a double-blind, triple arm, placebo-controlled randomized clinical trial. Participants will be recruited from Mount Sinai Hospital outpatient gynecology clinics. Recruitment, consent, randomization, procedure, and post-procedure survey will occur during the same visit. Each participant will be randomly assigned to one of three arms: 1. Intervention (10 cc 1% lidocaine paracervical block) 2. Placebo (10 cc paracervical injection of normal saline) 3. Control (gently tapping the cervicovaginal junction with a capped needle)
| Arm | Type | Receives |
|---|---|---|
| 1% Lidocaine Paracervical Block | Experimental | Drug: 1% Lidocaine Paracervical BlockA 22-gauge spinal needle will be loaded with 10 mL of 1% lidocaine with epinephrine. The injection will be instilled slowly over 60 seconds into the cervicovaginal junction in two equal areas at 2 and 10 o'clock. The injection is continuous from superficial to deep (3 cm). |
| Normal Saline Paracervical Injection | Sham comparator | Drug: Normal Saline Paracervical InjectionA 22-gauge spinal needle will be loaded with 10 mL of normal saline. The injection will be instilled slowly over 60 seconds into the cervicovaginal junction in two equal areas at 2 and 10 o'clock. The injection is continuous from superficial to deep (3 cm). |
| Capped Needle Control | No intervention | –A capped needle will gently be tapped on the cervicovaginal junction at two areas at 2 and 10 o'clock. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any participant presenting for an IUD placement, either for contraception or treatment of abnormal uterine bleeding or to regulate menstrual periods
- All IUDs (copper, hormonal) eligible
- All parities of patients are eligible
Key exclusion criteria (8 listed)
- Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours
- Confirmed pregnancy
- Any diagnosed chronic pain conditions (fibromyalgia, vaginismus, interstitial cystitis)
- Misoprostol administration within 24 hours of enrollment
- Known contraindications to IUD placement
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 |
|---|---|---|
| 1% Lidocaine Paracervical BlockA 22-gauge spinal needle will be loaded with 10 mL of 1% lidocaine with epinephrine. The injection will be instilled slowly over 60 seconds into the cervicovaginal junction in two equal areas at 2 and 10 o'clock. The injection is continuous from superficial to deep (3 cm). | Drug | 1% Lidocaine Paracervical Block |
| Normal Saline Paracervical InjectionA 22-gauge spinal needle will be loaded with 10 mL of normal saline. The injection will be instilled slowly over 60 seconds into the cervicovaginal junction in two equal areas at 2 and 10 o'clock. The injection is continuous from superficial to deep (3 cm). | Drug | Normal Saline Paracervical Injection |
Primary outcome
Global Pain Score
Time frame: Immediately following the procedure
Patient-reported overall pain score on the 100 mm Visual Analogus Scale (VAS). A score of 0 mm is the minimum, 100 mm is the maximum, with higher scores indicating more pain (i.e. worse outcome).
6 secondary outcomes
Pain at specific pain points
Time frame: Baseline, after injection or placebo, tenaculum placement, uterine sounding, IUD insertion, 1 minute post-procedure
Immediate complications following the procedure (i.e. vasovagal response, dizziness, local anesthetic toxicity syndrome)
Time frame: Immediately following the procedure
Length of time for analgesia
Time frame: Immediately following administration of the intervention, placebo, or control
Length of time for IUD placement
Time frame: Immediately following the procedure
Patient satisfaction
Time frame: Immediately following the procedure
Difficulty of IUD placement
Time frame: 1 is minimum (least diffiult) and 5 is maximum (most difficult). Higher scores are worse outcome as they are more difficult.
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 27 Jan 2025.
- Individual participant dataSharing planned: No
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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 2 study testing 1% Lidocaine Paracervical Block and Normal Saline Paracervical Injection in people with Contraception, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 3 inclusion and 8 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 27 Jan 2025. 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 Canada. 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?
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?
Global Pain Score (time frame: Immediately following the 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 27 Jan 2025.