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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% Lidocaine Paracervical Block | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Immediately following the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, after injection or placebo, tenaculum placement, uterine sounding, IUD insertion, 1 minute post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Toronto | Ontario | M5G1Z5 | Canada |
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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:
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We will employ two providers to ensure a double-blinded set-up. The first provider (Provider A) will open the allocation envelopes without the presence of the participant or second provider (Provider B).
Provider A will then enter the patient's room and introduce themselves. They will place the speculum, and administer either the intervention, placebo, or control and then leave the room after injection-related bleeding has stopped. After 3 minutes, the second provider (Provider B) will enter the room to place the IUD (including sounding and tenaculum placement) and will be unaware of the participant's treatment arm.
A standardized script will be used with all participants: "You may or not may feel a poke."
Both lidocaine and the control (normal saline) are odorless and clear, minimizing the risk of unblinding. All data will remain blinded until data analysis.
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| Normal Saline Paracervical Injection | Drug | 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). |
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| Immediate complications following the procedure (i.e. vasovagal response, dizziness, local anesthetic toxicity syndrome) | Provider reported based on events during the procedure | Immediately following the procedure |
| Length of time for analgesia | Stopwatch | Immediately following administration of the intervention, placebo, or control |
| Length of time for IUD placement | Stopwatch | Immediately following the procedure |
| Patient satisfaction | Survey-related questions, based on Likert scale and yes/no answers | Immediately following the procedure |
| Difficulty of IUD placement | Provider reported on Likert scale | 1 is minimum (least diffiult) and 5 is maximum (most difficult). Higher scores are worse outcome as they are more difficult. |