Pain Control for Intrauterine Device Placement Using Paracervical Block

Study Overview
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Brief Summary
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Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Currently there are no proven effective methods for reduction of pain during and after placement of modern IUDs. Paracervical block pain may decrease this placement pain.

Detailed Description
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Modern IUDs are highly effective long acting reversible forms of contraception. The Mirena IUD is 99.8% effective and the Paragard copper IUD is 99.2% effective in preventing pregnancy. Fear of IUD placement can be a barrier to obtaining this highly effective form of birth control. The current standard of care for pain management during and after IUD placement is no medication, as randomized control trials published to date have limited data regarding use of medications to decrease pain. There has been one trial to suggest that the use of naproxen with 1% lidocaine paracervical block (PCB) compared to PCB alone may decrease pain after IUD placement in primarily nulliparous patients. However, this study was with the much wider and no longer available Dalkon Shield IUD. In addition, this study did not show any significant decrease in pain scores during IUD placement. Studies to evaluate effectiveness of ibuprofen and misoprostol have shown no significant decrease in pain scores during and after IUD insertion, although the majority of participants in these studies were multiparous. There is some suggestion that 2% lidocaine gel one minute prior to IUD insertion may have some decrease in pain, although this study was poorly designed. Although there is no standard of care in regards to pain medication administration prior to IUD placement, providers often suggest paracervical prior IUD insertion among nulliparous women. Therefore the primary aim of this study is to determine whether a paracervical block (PCB) decreases pain associated with intrauterine device (IUD) placement compared to no paracervical block. We hypothesize that administration of a PCB of 20 mL 1% buffered lidocaine prior to IUD placement will decrease pain scores by at least 20mm on a visual analog scale at various time points during IUD placement when compared to no paracervical block.

Official Title
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Pain Control for Intrauterine Device Placement: A Randomized Controlled Trial of Paracervical Block

Conditions
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Pain Due to Intrauterine Contraceptive Device

Intervention / Treatment
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* Procedure: Paracervical Block (PCB)
* Procedure: No Paracervical Block (Sham PCB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nulliparous women English or Spanish speaking Present for intrauterine device placement for contraception or menorrhagia (in the case of Mirena IUD insertion). Exclusion Criteria: Pregnancy Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis) If the patient has taken any pain medications within 6 hours of enrollment, including aspirin or other NSAIDs Misoprostol administration within 24 hours of enrollment History of prior IUD insertion Known contraindications to IUD

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paracervical Block (PCB)<br>Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed. Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD. | Procedure: Paracervical Block (PCB)<br>* Drug: 1% Lidocaine Hydrochloride Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle. IUD placement then proceeds<br>|
| Sham Comparator: No Paracervical Block (Sham PCB)<br>Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed. Subject then receives Sham paracervical block with capped needle. Provider then places IUD. | Procedure: No Paracervical Block (Sham PCB)<br>* Drug: 1% Lidocaine Hydrochloride Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain. IUD placement then proceeds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain With Intrauterine Device (IUD) Placement | Distance (mm) from the left of the 100-mm visual analog scale (reflecting magnitude of pain) recorded at time of IUD Placement. Scale range is from 0mm (no pain) to 100mm (worst pain possible). A lower score (less pain) is considered a better outcome. | Moment of IUD insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Pain Scores for All Time Points | Distance (mm) from the left of the 100-mm visual analog scale of pain at various time points. Scale range is 0mm (no pain) to 100mm (worst pain possible). Lower scores are considered better outcomes. | Anticipation of procedure through 5 minutes after IUD placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Pain, Intrauterine Device, Paracervical Block