Clinical trial NCT05241496: Lidocaine Spray 10% Versus Oral Ibuprofen Tablets in Pain Control During Copper Intrauterine Device Insertion
Official title: Lidocaine Spray 10% Versus Oral Ibuprofen Tablets in Pain Control During Copper Intrauterine Device Insertion (A Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lidocaine Toxicity
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The intrauterine contraceptive device (IUD) is the most commonly used form of reversible contraception worldwide; the predominant type of product, the copper IUD (a plastic T-shaped device with copper affixed to it) was developed over 30 years ago and has become the standard bearer for intrauterine contraception, due to its long-term effectiveness, safety and affordability .

Inconsistent use and discontinuation of contraceptives are major causes of unintended pregnancy . The failure rate of the patch or ring is 20 times higher than that of long acting reversible contraceptives (LARCs) . Increasing acceptability and use of LARC methods like the intrauterine device (IUD) is an important strategy to reduce the risk of unintended pregnancy

Detailed description: The aim of this study is to This study is designed to compare between lidocaine spray 10% and oral ibuprofen as an adequate method for decreasing pain during copper intrauterine contraceptive device insertion .

Research question:

Which of both drugs ( local lidocaine spray 10% or oral ibuprofen tab.) is more effective in decreasing pain during IUD insertion ? Research Hypothesis In this current study, we hypothesize that using of local cervical lidocaine spray 10% prior to IUD insertion will decrease the pain more effectively than ibuprofen tablet 400 mg.

Eligibility criteria: Inclusion Criteria:

-Multiparous women in 3rd to 5th day of menstrual cycle 2- Women who were 6 weeks postpartum or if recently pregnant. 3- Accept to participate and provide consent

Exclusion Criteria:

* • A contraindication for IUD use such as a gynecological malignancy , sexually transmitted diseases, pelvic inflammatory disease or undiagnosed abnormal vaginal bleeding.

  * Suspicion of pregnancy .
  * Allergy to lidocaine or ibuprofen .
  * Copper allergy .
  * Any uterine abnormalities distorted uterine cavity as congenital anomalies, endometrial lesions, adenomyosis , and submucous myoma.
  * A psychological or neurological disorder associated with altered pain sensation.
  * MIRENA insertion.
  * Nulliparity.
  * History of failed intrauterine device insertion (uterine perforation, acute expulsion).

Primary outcomes:
measure: Self-reported pain score [ Time Frame: immediately after IUD insertion ]
timeFrame: immediately after IUD insertion
Secondary outcomes:
measure: Immediate complications related to IUD insertion [ Time Frame: one day after insertion]:
timeFrame: one day after insertion
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinSHAMS UNIV
Study officials:
affiliation: Ain Shams University
name: Alhassan M Khedr
role: STUDY_DIRECTOR
References:
citation: Aksoy H, Aksoy U, Ozyurt S, Acmaz G, Babayigit M. Lidocaine 10% spray to the cervix reduces pain during intrauterine device insertion: a double-blind randomised controlled trial. J Fam Plann Reprod Health Care. 2016 Apr;42(2):83-7. doi: 10.1136/jfprhc-2014-100917. Epub 2015 Mar 10.