Mepivacaine for pain relief at insertion of intrauterine contraception (MEPIC) – a randomized controlled trial.

Mepivacaine for pain relief at insertion of intrauterine contraception (MEPIC) – a triple-blind randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002271-36-SE

Enrollment

520

Registered

2020-12-07

Start date

2021-03-09

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insertion of intrauterine contraception

Interventions

Trade Name: Carbocain, Mepivacaine Accord Pharmaceutical Form: Injection INN or Proposed INN: mepivacaine Other descriptive name: MEPIVACAINE HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/milli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients = 18 years of age at risk of pregnancy • nulliparous • opting for intrauterine contraception • negative pregnancy test • willing to participate in the study after it has been explained orally and in written Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 520 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • previous conisation • known cervical stenosis • signs of ongoing genital infection • known uterine abnormality • conditions resulting in bleeding disorder • contraindication to any local anaesthetic • Body weight below 40 kilograms • IUC replacement • Use of other analgesia prior to or during insertion

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective: To evaluate the difference in pain score at the time of the insertion of the IUC between treatment and control group.;Secondary Objective: Secondary outcomes include overall experience of the procedure and pain score measured 10 minutes after insertion (efficacy), proportion of adverse events in each group (safety), and method recommendation to a friend (acceptability). Method acceptability among health care providers measured as ease to use, willing to include intrauterine instillation as standard routine for pain relief with IUD insertion, and recommendation to a fellow provider (acceptability).;Primary end point(s): •Pain score on a 100 mm VAS-scale measured immediately after IUC insertion. ;Timepoint(s) of evaluation of this end point: immediately after insertion	—

Measure

Time frame

Main Objective: Primary objective: To evaluate the difference in pain score at the time of the insertion of the IUC between treatment and control group.;Secondary Objective: Secondary outcomes include overall experience of the procedure and pain score measured 10 minutes after insertion (efficacy), proportion of adverse events in each group (safety), and method recommendation to a friend (acceptability). Method acceptability among health care providers measured as ease to use, willing to include intrauterine instillation as standard routine for pain relief with IUD insertion, and recommendation to a fellow provider (acceptability).;Primary end point(s): •Pain score on a 100 mm VAS-scale measured immediately after IUC insertion. ;Timepoint(s) of evaluation of this end point: immediately after insertion

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Secondary

Measure	Time frame
Secondary end point(s): Efficacy variables 1. Overall experience of the procedure rated as “easier than expected”, “as expected” and “worse than expected” 2. Pain score on a 100 mm VAS-scale Safety variables 3. Allergic reaction related to the study drug (number of patients in group allocated to active study drug) 4. Vasovagal reactions (proportion in each group) 5. Failed insertion (proportion in each group) 6. Other side effects measured at follow up (in each group respectively) - IUC expulsion - Infections - Hospital admission or contact with healthcare system Acceptability variables Patients 7. Would you recommend this method for pain relief to a friend? (yes/no). 8. Would you opt for an IUD again if the procedure was like this?” (yes/no). 9. “Was the pain at insertion worth having the IUD inserted” (yes/no). 10. “The pain you felt during the insertion was…?” tolerable/not tolerable. Healthcare provider: 11. “Rate how easy it was to perform the 10 ml instillation from a technical perspective? Numerical rating scale evaluated after each instillation. 1 very easy, 2 easy, 3 neither easy nor difficult, 4 difficult, 5 very difficult. Analyzed as difference in proportion of instillations receiving each rating. 12. Are you willing to include intrauterine instillation as standard routine for pain relief with IUD insertion (yes/no) 13. Would you recommend this method to a fellow provider (yes/no). Number of respondents in each group will be presented. ;Timepoint(s) of evaluation of this end point: Efficacy variables: Patient 10 minutes after insertion: 1 and 2 safety variables evaluated during study visit: 3, 4, 5 From first study visit until End of trial: 6 Acceptability variables: Assessment at 10 minutes after insertion: 7, 8, 10, Rated after instillation prior to insertion: 11 3 months post insertion: 9. Rate how easy it was to perform the10 ml instillation. After each instillation. After last instillation at each clinic: 12, 13	—

Measure

Time frame

Secondary end point(s): Efficacy variables 1. Overall experience of the procedure rated as “easier than expected”, “as expected” and “worse than expected” 2. Pain score on a 100 mm VAS-scale Safety variables 3. Allergic reaction related to the study drug (number of patients in group allocated to active study drug) 4. Vasovagal reactions (proportion in each group) 5. Failed insertion (proportion in each group) 6. Other side effects measured at follow up (in each group respectively) - IUC expulsion - Infections - Hospital admission or contact with healthcare system Acceptability variables Patients 7. Would you recommend this method for pain relief to a friend? (yes/no). 8. Would you opt for an IUD again if the procedure was like this?” (yes/no). 9. “Was the pain at insertion worth having the IUD inserted” (yes/no). 10. “The pain you felt during the insertion was…?” tolerable/not tolerable. Healthcare provider: 11. “Rate how easy it was to perform the 10 ml instillation from a technical perspective? Numerical rating scale evaluated after each instillation. 1 very easy, 2 easy, 3 neither easy nor difficult, 4 difficult, 5 very difficult. Analyzed as difference in proportion of instillations receiving each rating. 12. Are you willing to include intrauterine instillation as standard routine for pain relief with IUD insertion (yes/no) 13. Would you recommend this method to a fellow provider (yes/no). Number of respondents in each group will be presented. ;Timepoint(s) of evaluation of this end point: Efficacy variables: Patient 10 minutes after insertion: 1 and 2 safety variables evaluated during study visit: 3, 4, 5 From first study visit until End of trial: 6 Acceptability variables: Assessment at 10 minutes after insertion: 7, 8, 10, Rated after instillation prior to insertion: 11 3 months post insertion: 9. Rate how easy it was to perform the10 ml instillation. After each instillation. After last instillation at each clinic: 12, 13

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Countries

Sweden

Contacts

Public ContactHelena Kopp Kallner

Karolinska Institutet

helena.kopp-kallner@ki.se704402070

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026