10% Lidocaine Spray for Intrauterine Device Insertion (LidocaineIUD)

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Contraception; Intrauterine Device

Treatments: Drug: lidocaine spray; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03870711

Si 240/2018

Details and patient eligibility

About

Intrauterine device (IUD) insertion is a procedure that can cause pain. Fear of pain during IUD insertion is a barrier to use of this method. Currently, there is no recommended standard method for reducing pain during this procedure. From Cochrane Database 2015, some lidocaine formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection, could reduce pain during IUD insertion, but there is limited data on effect of lidocaine spray on reducing pain during insertion of IUD.

Full description

Intrauterine device (IUD) is a high efficacy long-acting reversible contraceptive method. However, IUD insertion is a procedure that require well-trained medical personnel and can cause pain in several steps during insertion such as applying tenaculum, applying uterine sound and insertion of IUD. Fear of pain during IUD insertion is a barrier to use of this contraceptive method. Previous researches reported mean pain score with using visual analog scale (VAS) moderated pain (4.7/10 and 34.7-51.2/100). In several countries, pain control is used before IUD insertion procedure. Currently, there is no recommended standard method for reducing pain during this procedure. From Cochrane Database 2015, some lidocaine formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection, could reduce pain during IUD insertion, but there is limited data on effect of lidocaine spray on reducing pain during insertion of IUD.

Lidocaine is introduced to use for pain relieving in medical procedures with advantages of rapid action and minimal side effects.10% Lidocaine spray is a form of local anesthetic method that use in obstetrics and gynecology procedures and has favorable efficacy in reducing pain. Nevertheless, there were limited studies of 10% Lidocaine spray during IUD insertion. In this study, we investigate pain during IUD insertion using lidocaine spray compared with placebo.

Enrollment: 124 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Woman who required for Copper T IUD insertion
• Body mass index 18.5 - 30 kg/m2
• Communicable with Thai language
• New IUD user

Exclusion criteria

• Suspicion of pregnancy
• Puerperal sepsis/Immediate post-septic abortion
• Untreated abnormal uterine bleeding
• Uterine anomaly/abnormal pathology distorting the uterine cavity
• Current pelvic inflammatory disease
• Untreated cervicitis/vaginitis
• Wilson's disease
• Copper allergy
• known hypersensitivity to local anaesthetic
• Analgesic or anxiolytic use within the last 24 h before the procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups, including a placebo group

group A

Experimental group

Description:

10% lidocaine spray

Treatment:

Drug: lidocaine spray

group B

Placebo Comparator group

Description:

sterile water

Treatment:

Drug: Placebo