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Analgesia for Insertion of Intrauterine Contraception

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT02078063
Collaborator
(none)
86
Enrollment
2
Locations
2
Arms
48
Duration (Months)
43
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Mepivacaine for Pain Relief at Insertion of Intrauterine Contraception
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Nov 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mepivacaine

10 ml of Mepivacaine for injection (Carbocain®) 10 mg/ml instilled into the uterus through a hydrosonography catheter

Drug: Mepivacaine
10 ml of Mepivacaine for injection (Carbocain®) 10 mg/ml instilled into the uterus through a hydrosonography catheter
Other Names:
  • Carbocain (R)

    		•
    Placebo Comparator: NaCL

    10 ml NaCl 9mg/ml instilled into the uterus through a hydrosonography catheter

    Drug: Placebo
    10 ml of NaCl 0.9 mg/ml instilled into the uterus through a hydrosonography catheter

    Outcome Measures

    Primary Outcome Measures

    1. pain [On day of insertion]

      difference in pain score (VAS)at the time of the insertion of the IUC between treatment and control group.

    Secondary Outcome Measures

    1. Acceptability [30 minutes after insertion]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • over 18 years of age and

    • opting for IUC for contraception

    • with a negative pregnancy test

    • willing to participate in the study after it has been explained orally and in written

    Exclusion Criteria:

    • previous conisation,

    • known cervical stenosis,

    • signs of ongoing genital infection,

    • known uterine abnormality,

    • any condition resulting in bleeding disorder or contraindication to any local anestetic will be excluded

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept of Obstetrics and Gynecology, Danderyd Hospital Stockholm Sweden 182 88
    2 Upplands Väsby Ungdomsmottagning Stockholm Sweden

    Sponsors and Collaborators

    • Karolinska Institutet

    Investigators

    • Principal Investigator: Helena Kopp Kallner, MD, PhD, Karolinska Institutet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Helena Kopp Kallner, MD, PhD, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT02078063
    Other Study ID Numbers:
    • WIUC13 version II
    First Posted:
    Mar 5, 2014
    Last Update Posted:
    Apr 26, 2018
    Last Verified:
    Apr 1, 2018
    Additional relevant MeSH terms:
    Mepivacaine

    Study Results

    No Results Posted as of Apr 26, 2018