Clinical trial NCT03870711: 10% Lidocaine Spray for Intrauterine Device Insertion
Official title: 10% Lidocaine Spray for Pain Control During Intrauterine Device Insertion: A Randomized, Double-blinded, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Intrauterine Device
Keywords: Intrauterine device
lidocaine spray
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of 10% Lidocaine spray in reducing pain during IUD insertion: visual analog scale
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: Side effects of 10% Lidocaine spray
timeFrame: 20 minutes after the procedure
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Nalinee Panichyawat
state: Bangkok
Study officials:
affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj hospital
name: Nalinee Panichyawat
role: PRINCIPAL_INVESTIGATOR
References:
citation: Panichyawat N, Mongkornthong T, Wongwananuruk T, Sirimai K. 10% lidocaine spray for pain control during intrauterine device insertion: a randomised, double-blind, placebo-controlled trial. BMJ Sex Reprod Health. 2021 Jul;47(3):159-165. doi: 10.1136/bmjsrh-2020-200670. Epub 2020 Jun 26.