Mepivacaine
Drug10 ml of Mepivacaine for injection (Carbocain®) 10 mg/ml instilled into the uterus through a hydrosonography catheter
Other names: Carbocain (R)
Completed
NCT Number: NCT02078063
Analgesia for Insertion of Intrauterine Contraception
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Phase 3
Primary location
Dept of Obstetrics and Gynecology, Danderyd Hospital, Stockholm, Sweden
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo
Drug10 ml of NaCl 0.9 mg/ml instilled into the uterus through a hydrosonography catheter
Primary outcomes
-
pain
Time frame: On day of insertion
difference in pain score (VAS)at the time of the insertion of the IUC between treatment and control group.
Secondary outcomes
-
Acceptability
Time frame: 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).
Sponsors and collaborators
Lead sponsor
Karolinska Institutet
Other
Registry information
Official study title
Mepivacaine for Pain Relief at Insertion of Intrauterine Contraception
Important dates
- Study start
- 2013
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Mar 5, 2014
- Registry last updated
- Apr 26, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.