Lidocaine Spray 10% Versus Oral Ibuprofen Tablets in Pain Control During Copper Intrauterine Device Insertion

Lidocaine Spray 10% Versus Oral Ibuprofen Tablets in Pain Control During Copper Intrauterine Device Insertion (A Randomized Controlled Trial)

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

Study Overview

• Status: Recruiting
• Conditions: Lidocaine Toxicity
• Intervention / Treatment: Diagnostic test: The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marina Rm Ghaly, doctor; Phone Number: +20 127 186 9711; Email: dr.marina_ramsis@med.asu.edu.eg
• Study Contact Backup: Name: Rofaida MA Taha, Doctor; Phone Number: +20 105017338; Email: RofaidaMohamed@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11531
    • Recruiting
    • AinSHAMS UNIV
    • Contact: Marina Rm Ghaly, doctor; Phone Number: +20 127 186 9711; Email: dr.marina_ramsis@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Marina Ramsis; In the other group, 70 women will be randomly assigned for ibuprofen; participants will take 1 tablet (400mg) immediately & clinicians will wait at least 45 minutes before inserting the copper IUD

Diagnostic test: The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration; Lidocaine in spray form is a simple and convenient local anaesthetic with minimal adverse effects and is often used in dentistry for oral mucosal anaesthesia during minor surgical interventions. The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration. Lidocaine acts by stabilization of the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action (Hüseyin Aksoy et al. ,2016 ) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported pain score [ Time Frame: immediately after IUD insertion ]	The visual analog scale (VAS ) pain score reported by participants immediately after IUD insertion .Pain scores will be measured using a visual analogue scale (VAS) consisting of a 10 cm horizontal straight line on which 0 cm corresponds to no pain and 10 cm to the worst pain. VAS is rated as 0 for no pain, 1-3 for mild pain, 4-6 for average pain, and 7-9 for severe pain and 10 for extremely severe pain an individual can experience . A research assistant standing beside the woman will hold the VAS sheet for the participant to select the point that corresponds to the level of pain she will experience after IUD insertion .	immediately after IUD insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate complications related to IUD insertion [ Time Frame: one day after insertion]:	Immediate complications related to IUD insertion [ Time Frame: one day after insertion]: The immediate complications related to IUD insertion such as : Failure of insertion .; Vasovagal reaction .; The number of women who will need analgesics after insertion.	one day after insertion

Collaborators and Investigators

• Sponsor: Marina Ramsis Aziz Ghaly
• Investigators: Study Director: Alhassan M Khedr, Ain Shams University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Anticipated): December 14, 2022
• Study Completion (Anticipated): October 10, 2023

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: February 5, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: AinShams univ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No