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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain During Intrauterine Device Insertion
• Intervention / Treatment: Drug: Lidocaine HCl 1%; Drug: Prilocaine, Lidocaine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Aprill D Susin, NP, PhD(c); Phone Number: 19029890116; Email: aprill.susin@queensu.ca
• Study Contact Backup: Name: Monakshi Sawhney, NP, PhD; Phone Number: 14168160487; Email: mona.sawhney@queensu.ca

Study Locations

• Canada
  • Nova Scotia
    • Dartmouth, Nova Scotia, Canada, B2W 2S7
      • Woodlawn Medical Clinic
      • Contact: Aprill Susin, NP; Phone Number: 19029890116; Email: aprillnegus@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prilocaine Lidocaine Arm; Participants will received prilocaine lidocaine injection, acetaminophen and naproxen	Drug: Lidocaine HCl 1%; Participants will receive 1% lidocaine injected into the cervix (10mls) 5 minutes prior to the procedure; Other Names: Lidocaine
Active Comparator: Lidocaine injection; Participants will receive lidocaine injection, acetaminophen and naproxen	Drug: 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.; Other Names: EMLA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale	Zero is equivalent to no pain and 10 indicates the worst possible pain	Baseline to end of treatment on day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State Trait Anxiety Inventory	Participants will answer a questionnaire on their level of anxiety.	Baseline
McGill Pain Questionnaire	Participants will describe the pain/ if any they experienced during the procedure	end of treatment on day 1
Ease of Insertion	Clinicians inserting the intrauterine device will rate on a numerical scale the difficulty of inserting the device, zero being extremely easy and ten being extremely difficult.	end of treatment on day 1
Non Pharmacological Measures	Participants will answer a questionnaire on the type of nonpharmacological measures they used during the procedure	end of treatment on day 1
Adverse Reactions	Participants will answer a questionnaire about any adverse reactions they may have experienced.	at day 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Information	Participants will answer a questionnaire about their current and past health. In addition, to sociodemographic information ( such as age, sex, gender)	baseline

Collaborators and Investigators

• Sponsor: Monakshi Sawhney
• Collaborators: Queen's University, Kingston, Ontario
• Investigators: Principal Investigator: Monakshi Sawhney, NP, PhD, Queen's University

Publications and helpful links

General Publications

• Werger, M., Kirubarajan, A., Gryn, A., Ivanisevic, S., Salim, S., Wang, S., Huszti, E., Flamer, D., Spitzer, R., Jacobson, M., & Sobel, M. (2025). A double-blind, triple-arm randomized controlled trial of 1% lidocaine paracervical block for intrauterine device (IUD) insertion. Journal of Obstetrics and Gynaecology Canada, 47(6), Article 102901. https://doi.org/10.1016/j.jogc.2025.102901
• Tavakolian, S., Doulabi, M. A., Baghban, A. A., Mortazavi, A., & Ghorbani, M. (2015). Lidocaine-prilocaine cream as analgesia for IUD insertion: A prospective, randomized, controlled, triple blinded study. Global Journal of Health Science, 7(4), 399-404. https://doi.org/10.5539/gjhs.v7n4p399
• Samy, A., Abbas, A. M., Mahmoud, M., Taher, A., Awad, M. H., El husseiny, T., Hussein, M., Ramadan, M., Shalaby, M. A., El sharkawy, M., Hatem, D., Alaa-El-din Wali, A., Abd-el-fatah, S. M., Hussein, A. H., & Haggag, H (2019). Evaluating different pain lowering medications during intrauterine device insertion: A systematic review and network meta-analysis. Fertility and Sterility, 111(3), 553-61. e4. https://doi.org/10.1016/j.fertnstert.2018.11.012
• Nguyen, L., Lamarche, L., Lennox, R., Ramdyal, A., Patel, T., Black, M., & Mangin, D. (2020). Strategies to mitigate anxiety and pain in intrauterine device insertion: A systematic review. Journal of Obstetrics and Gynecology Canada. 42(9), 1138-1146.
• Karasu, Y., Comert, D.K., Karadag, B., & Ergun, Y. (2017). Lidocaine for pain control during intrauterine device insertion. The Journal of Obstetrics and Gynaecology Research, 43(6), 1061-1066. https://doi.org/10.1111/jog.13308
• Mody, S. K., Farala, J. P., Jimenez, B., Nishikawa, M., & Ngo, L. L. (2018). Paracervical block for intrauterine device placement among nulliparous women: A randomized controlled trial. Obstetrics and Gynecology, 132(3), 575-582. https://doi.org/10.1097/AOG.0000000000002790
• Lopes-Garcia, E. A., Carmona, E. V., Monteiro, I., & Bahamondes, L. (2023). Assessment of pain and ease of intrauterine device placement according to type of device, parity, and mode of delivery. The European Journal of Contraception & Reproductive Health Care, 28(3), 163-167. https://doi.org/10.1080/13625187.2023.2189500
• Hunter, T. A., Sonalkar, S., Schreiber, C. A., Perriera, L. K., Sammel, M. D., & Akers, A. Y. (2020). Anticipated Pain During Intrauterine Device Insertion. Journal of Pediatric & Adolescent Gynecology, 33(1), 27-32. https://doi.org/10.1016/j.jpag.2019.09.007
• Hawker, G. A., Mian, S., Kendzerska, T., & French, M. (2011). Measures of adult pain: Visual analog scale for pain (VAS pain), numeric rating scale for pain (NRS pain), mcgill pain questionnaire (MPQ), short-form mcgill pain questionnaire (SF-MPQ), chronic pain grade scale (CPGS), short form-36 bodily pain scale (SF-36 BPS), and measure of intermittent and constant osteoarthritis pain (ICOAP). Arthritis Care & Research, 63(S11), S240-S252. https://doi.org/10.1002/acr.20543
• de Oliveira, E. C. F., Baêta, T., Brant, A. P. C., Silva-Filho, A., & Rocha, A. L. L. (2021). Use of naproxen versus intracervical block for pain control during the 52-mg levonorgestrel-releasing intrauterine system insertion in young women: A multivariate analysis of a randomized controlled trial. BMC Women's Health, 21(1), Article 377. https://doi.org/10.1186/s12905-021-01521-z
• Black, A., Guilbert, A., Costescu, D., Dunn, S., Fisher, W., Kives, S., Mirosh, M., Norman, W., Pymar, H., Reid, R., Roy, G., Varto, H., Waddington, A., Wagner, M.S., & Whelan, A.M. (2016). Canadian contraception consensus (part 3 of 4): Chapter 7- Intrauterine contraception. Journal of Obstetrics and Gynecology Canada, 38(2), 182-222. https://doi.org/10.1016/j.jogc.2015.12.002
• Bayer, L. L., Ahuja, S., Allen, R. H., Levine, J., Ngo, L. L., & Mody, S. (2025). Best practices for reducing pain associated with intrauterine device placement. American Journal of Obstetrics & Gynecology, 232(5), 409-421. Doi:10.1016/j.ajog.2025.01.039.
• Akers, A. Y., Steinway, C., Sonalkar, S., Perriera, L. K., Schreiber, C., Harding, J., & Garcia-Espana, J. F. (2017). Reducing pain during intrauterine device insertion: A randomized controlled trial in adolescents and young women. Obstetrics & Gynecology, 130(4), 795-802. https://doi.org/10.1097/AOG.0000000000002242
• Abbas, A. M., Abdellah, M. S., Khalaf, M., Bahloul, M., Abdellah, N. H., Ali, M. K., & Abdelmagied, A. M. (2017). Effect of cervical lidocaine-prilocaine cream on pain perception during copper t380A intrauterine device insertion among parous women: A randomized double-blind controlled trial. Contraception, 95(3), 251-256. https://doi.org/10.1016/j.contraception.2016.10.011

Study record dates

Study Major Dates

• Study Start (Estimated): April 14, 2026
• Primary Completion (Estimated): April 14, 2027
• Study Completion (Estimated): April 14, 2027

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: pain; lidocaine; contraception; intrauterine device; prilocaine-lidocaine
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Organic Chemicals; Pharmaceutical Preparations; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Drug Combinations; Prilocaine; Lidocaine, Prilocaine Drug Combination; Lidocaine
• Other Study ID Numbers: The PLAN IUD Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No