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Use of long acting reversible contraception (LARC) such as implants or intrauterine contraception (IUC) has been shown to reduce repeat abortions. LARCs have the advantage of being independent of user error and are considered to be underused, especially among young individuals where oral methods have high rates of user failure. IUC is often underused in young or nulliparous women due to fear of pain at insertion.
10 ml of mepivacaine (10mg/ml) or 10ml of sodium hydrochloride will be injected into the uterine cavity through a hydrosonography catheter before the tenaculum has been applied but prior to sounding and to insertion of the IUC.
The investigators' hypothesis is that instillation of 10 ml (10mg/ml) mepivacaine though a hydrosonography catheter prior to any instrument placement will provide more effective pain relief than instillation of 10 ml placebo (sodium chloride 9mg/ml).
Primary objective: To evaluate the difference in pain score at the time of the insertion of the IUC between treatment and control group.
Secondary objectives: To evaluate acceptability of the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepivacaine | Experimental | 10 ml of Mepivacaine for injection (Carbocain®) 10 mg/ml instilled into the uterus through a hydrosonography catheter |
|
| NaCL | Placebo Comparator | 10 ml NaCl 9mg/ml instilled into the uterus through a hydrosonography catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepivacaine | Drug | 10 ml of Mepivacaine for injection (Carbocain®) 10 mg/ml instilled into the uterus through a hydrosonography catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain | difference in pain score (VAS)at the time of the insertion of the IUC between treatment and control group. | On day of insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | They will be asked if the would opt to have this type of pain relief were the ever to insert a new IUC (yes/no), if they would recommend this type of pain relief to any other women (yes/no) and to state how the procedure was compared to their expectations (worse/as expected/better). | 30 minutes after insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helena Kopp Kallner, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Obstetrics and Gynecology, Danderyd Hospital | Stockholm | 182 88 | Sweden | |||
| Upplands Väsby Ungdomsmottagning |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30831101 | Derived | Envall N, Lagercrantz HG, Sunesson J, Kopp Kallner H. Intrauterine mepivacaine instillation for pain relief during intrauterine device insertion in nulliparous women: a double-blind, randomized, controlled trial. Contraception. 2019 Jun;99(6):335-339. doi: 10.1016/j.contraception.2019.02.003. Epub 2019 Mar 1. |
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| ID | Term |
|---|---|
| D008619 | Mepivacaine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | 10 ml of NaCl 0.9 mg/ml instilled into the uterus through a hydrosonography catheter |
|
| Stockholm |
| Sweden |