The Effectiveness of Topical Prilocaine-Lidocaine Cream Plus Acetaminophen and Naproxen Compared to Lidocaine Injection Plus Acetaminophen and Naproxen to Manage Pain During IntraUterine Device Insertion

Официальное название

The PLAN IUD Trial: The Effectiveness of Topical Prilocaine-Lidocaine Cream Plus Acetaminophen and Naproxen Compared to Lidocaine Injection Plus Acetaminophen and Naproxen to Manage Pain During IntraUterine Device Insertion: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if two pain medications used to treat pain during intrauterine device insertions work in persons with a uterus. It will also learn about the safety of the two study medications. The main questions it aims to answer are: Does prilocaine lidocaine, acetaminophen and naproxen or lidocaine injection, acetaminophen and naproxen reduce pain during intrauterine device insertions. Researchers will compare prilocaine lidocaine cream and lidocaine injection to see if it treats pain during an intrauterine device insertion. Participants will be asked to: * take acetaminophen and naproxen prior to the procedure. * receive either prilocaine-lidocaine or lidocaine injection during the procedure * to fill out a survey on past medical history, anxiety, and pain.

Подробное описание

Intrauterine devices (IUDs) are one of the most recommended forms of birth control. An IUD is a small device placed inside the uterus to prevent pregnancy. Many individuals prefer the IUD as it does not require taking a pill every day. These devices are typically inserted in the patient's nurse practitioner's or physician's clinic. Intrauterine devices are very effective in preventing an unwanted pregnancy; however, the procedure can be painful. Without medication, individuals have described the pain as moderate to severe. Pain and the fear of experiencing pain are one reason why individuals choose not to get an IUD and choose less effective birth control. There are several pain relief options to help alleviate pain during IUD insertions, such as acetaminophen, naproxen, and local freezing medications. The local medications can be given as a cream or an injection. Unfortunately, not all health care providers offer pain relief options, and there is no consensus on which is the most effective. This study aims to use multiple pain relief options and compare the cream and the injectable medication to see which combination is more effective.

A total of 66 participants will take part in this study. Each participant will be randomly assigned to one of the pain management groups: anesthetic cream or injection. Before the procedure, participants will answer a questionnaire about their general health, demographics, and anxiety. Participants will be given acetaminophen and naproxen 45 minutes before the start of the procedure. During the procedure, participants will be asked to rate their pain on a scale of 0 to 10. After the procedure, participants will be asked to describe the pain they experienced.

The acute care pain guidelines recommend the use of multiple medications and the use of non-pharmacological methods such as distraction for pain relief. Prior studies have focused on one pain relief option for pain during IUD insertions. In addition, no prior study has compared the analgesic cream against the injectable analgesic. Conducting this study will aid in a clearer understanding of which pain relief measure is appropriate to use during IUD insertions. If both pain relief options are equally effective, then individuals will have a choice between the use of a cream or an injection for pain relief; the latter of which can also inflict pain.

The results of this study will be shared at conferences across the country and through scientific journals. The results will facilitate conversations among health care providers about appropriate pain management. Patients can use this information to advocate for improved pain relief during their procedures, thereby empowering persons with a cervix during gynecological procedures. The research team is largely made up of women who are nurses or nurse practitioners, a field that is predominantly female. This study will contribute to the growth of nurse-led research in women's reproductive health and can be used to inform decision-making and policy changes for improved pain control in women's reproductive health.

Вмешательства

• Препарат Prilocaine, Lidocaine
  Participants in this arm will receive prilocaine lidocaine cream to their cervix (4 grams) to their cervix 5 minutes prior to the procedure.
• Препарат Lidocaine HCl 1%
  Participants will receive 1% lidocaine injected into the cervix (10mls) 5 minutes prior to the procedure

Первичные конечные точки

• Numerical Rating Scale [Срок оценки: Baseline to end of treatment on day 1]

Вторичные конечные точки (5)

• State Trait Anxiety Inventory [Срок оценки: Baseline]
• McGill Pain Questionnaire [Срок оценки: end of treatment on day 1]
• Ease of Insertion [Срок оценки: end of treatment on day 1]
• Non Pharmacological Measures [Срок оценки: end of treatment on day 1]
• Adverse Reactions [Срок оценки: at day 2]

Критерии участия

Критерии включения

• Nulliparous, parous female or non operative trans male
• Participants want to have an IUD for contraception
• Able to provide consent
• Participants are between the ages of 18-45 years old
• Individuals must meet the medical eligibility criteria for an IUD

Критерии исключения

• pregnant or if pregnancy can not be ruled out the day of insertion
• have abnormal uterine bleeding that has not been investigated
• Lupus
• liver disease
• progesterone sensitive tumors
• molar pregnancy
• gynecological malignancy
• breast cancer
• clotting disorders
• uterine anomalies
• septic abortion within last three months
• allergy to progesterone or copper
• pelvic inflammatory disease
• acute malignancies affecting blood
• bacterial endocarditis
• methemoglobinemia
• allergy to prilocaine-lidocaine cream
• actively breastfeeding
• Participants taking beta-blockers and/ or antiarrhythmic drugs
• Individuals who have taken opioids or benzodiazepines within 24 hours prior to the procedure
• Participants who are currently using an IUD

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Woodlawn Medical Clinic — Dartmouth

Публикации

• Kirubarajan A, Gryn A, Werger M, Salim S, Ivanisevic S, Liu J, Wang S, Huszti E, Jacobson M, Flamer D, Spitzer RF, Sobel M. A double-blind, triple-arm randomized controlled trial of 1% lidocaine paracervical block for intrauterine device (IUD) insertion. Contraception. 2026 Aug;160:111393. doi: 10.1016/j.contraception.2026.111393. Epub 2026 Jan 24. PMID 41587631
• Tavakolian S, Doulabi MA, Baghban AA, Mortazavi A, Ghorbani M. Lidocaine-Prilocaine Cream as Analgesia for IUD Insertion: A Prospective, Randomized, Controlled, Triple Blinded Study. Glob J Health Sci. 2015 Jan 27;7(4):399-404. doi: 10.5539/gjhs.v7n4p399. PMID 25946948
• Samy A, Abbas AM, Mahmoud M, Taher A, Awad MH, El Husseiny T, Hussein M, Ramadan M, Shalaby MA, El Sharkawy M, Hatem D, Alaa-El-Din Wali A, Abd-El-Fatah SM, Hussein AH, Haggag H. Evaluating different pain lowering medications during intrauterine device insertion: a systematic review and network meta-analysis. Fertil Steril. 2019 Mar;111(3):553-561.e4. doi: 10.1016/j.fertnstert.2018.11.012. Epub 20 PMID 30611553
• Nguyen L, Lamarche L, Lennox R, Ramdyal A, Patel T, Black M, Mangin D. Strategies to Mitigate Anxiety and Pain in Intrauterine Device Insertion: A Systematic Review. J Obstet Gynaecol Can. 2020 Sep;42(9):1138-1146.e2. doi: 10.1016/j.jogc.2019.09.014. Epub 2019 Dec 25. PMID 31882291
• Karasu Y, Comert DK, Karadag B, Ergun Y. Lidocaine for pain control during intrauterine device insertion. J Obstet Gynaecol Res. 2017 Jun;43(6):1061-1066. doi: 10.1111/jog.13308. Epub 2017 May 15. PMID 28503818
• Mody SK, Farala JP, Jimenez B, Nishikawa M, Ngo LL. Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):575-582. doi: 10.1097/AOG.0000000000002790. PMID 30095776
• Lopes-Garcia EA, Carmona EV, Monteiro I, Bahamondes L. Assessment of pain and ease of intrauterine device placement according to type of device, parity, and mode of delivery. Eur J Contracept Reprod Health Care. 2023 Jun;28(3):163-167. doi: 10.1080/13625187.2023.2189500. Epub 2023 Mar 24. PMID 36961099
• Hunter TA, Sonalkar S, Schreiber CA, Perriera LK, Sammel MD, Akers AY. Anticipated Pain During Intrauterine Device Insertion. J Pediatr Adolesc Gynecol. 2020 Feb;33(1):27-32. doi: 10.1016/j.jpag.2019.09.007. Epub 2019 Sep 26. PMID 31563628

Идентификаторы

NCT: NCT07546370 · The PLAN IUD Trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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