Pain Control for Intrauterine Device Placement Using Paracervical Block
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| ClinicalTrials.gov Identifier: NCT02219308 |
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Recruitment Status :
Completed
First Posted : August 18, 2014
Results First Posted : November 1, 2019
Last Update Posted : November 1, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain Due to Intrauterine Contraceptive Device | Procedure: Paracervical Block (PCB) Procedure: No Paracervical Block (Sham PCB) | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 67 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Pain Control for Intrauterine Device Placement: A Randomized Controlled Trial of Paracervical Block |
| Actual Study Start Date : | October 2014 |
| Actual Primary Completion Date : | October 2017 |
| Actual Study Completion Date : | October 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Paracervical Block (PCB)
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)
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 |
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Sham Comparator: No Paracervical Block (Sham PCB)
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)
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 |
- Pain With Intrauterine Device (IUD) Placement [ Time Frame: Moment of IUD insertion ]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.
- Median Pain Scores for All Time Points [ Time Frame: Anticipation of procedure through 5 minutes after IUD placement ]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.
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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219308
| United States, California | |
| UCSD | |
| San Diego, California, United States, 92103 | |
| Planned Parenthood Mission Bay Parker Center | |
| San Diego, California, United States, 92109 | |
| Principal Investigator: | Sheila Mody, MD MPH | UCSD |
Documents provided by Sheila Mody, University of California, San Diego:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sheila Mody, Women's Reproductive Health Research (K12) Scholar, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT02219308 |
| Other Study ID Numbers: |
141025 |
| First Posted: | August 18, 2014 Key Record Dates |
| Results First Posted: | November 1, 2019 |
| Last Update Posted: | November 1, 2019 |
| Last Verified: | October 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Contraception Pain Intrauterine Device Paracervical Block |