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

Primary Purpose

Lidocaine Toxicity

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration

About this trial

This is an interventional treatment trial for Lidocaine Toxicity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

AinSHAMS UNIVRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Marina Ramsis

Arm Description

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

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05241496

First Posted

January 17, 2022

Last Updated

July 18, 2022

Sponsor

Marina Ramsis Aziz Ghaly

1. Study Identification

Unique Protocol Identification Number

NCT05241496

Brief Title

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

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 15, 2021 (Actual)

Primary Completion Date

December 14, 2022 (Anticipated)

Study Completion Date

October 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Marina Ramsis Aziz Ghaly

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lidocaine Toxicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Marina Ramsis

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration

Intervention Description

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 ) .

Primary Outcome Measure Information:

Title

Self-reported pain score [ Time Frame: immediately after IUD insertion ]

Description

Time Frame

immediately after IUD insertion

Secondary Outcome Measure Information:

Title

Immediate complications related to IUD insertion [ Time Frame: one day after insertion]:

Description

Time Frame

one day after insertion

10. Eligibility

Sex

Female

Gender Based

Yes

Accepts Healthy Volunteers

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marina RM Ghaly, Doctor

Phone

+20 127 186 9711

dr.marina_ramsis@med.asu.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Rofaida MA Taha, Doctor

Phone

+20 105017338

RofaidaMohamed@med.asu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alhassan M Khedr

Organizational Affiliation

Ain Shams University

Official's Role

Study Director

Facility Information:

Facility Name

AinSHAMS UNIV

City

Cairo

ZIP/Postal Code

11531

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marina Rm Ghaly, doctor

Phone

+20 127 186 9711

dr.marina_ramsis@med.asu.edu.eg

First Name & Middle Initial & Last Name & Degree

doctor

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25759418

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.

Results Reference

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

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