Analgesia for Insertion of Intrauterine Contraception

Mepivacaine for Pain Relief at 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.

Study Overview

• Status: Completed
• Conditions: Insertion of Intrauterine Contraception
• Intervention / Treatment: Drug: Mepivacaine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 182 88
    • Dept of Obstetrics and Gynecology, Danderyd Hospital
  • Stockholm, Sweden
    • Upplands Väsby Ungdomsmottagning

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: March 3, 2014
• First Posted (Estimate): March 5, 2014

Study Record Updates

• Last Update Posted (Actual): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Mepivacaine
• Other Study ID Numbers: WIUC13 version II