Lidocaine In-situ Gel Prior to Intrauterine Device Insertion in Women With no Previous Vaginal Delivery

NCT03166111 — Phase 3, Completed, 216 participants, Assiut University

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Effect of Self-administered Lidocaine In-situ Gel Prior to Intrauterine Device Insertion in Women With no Previous Vaginal Delivery: A Randomized Controlled Study

Registry	NCT03166111
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	216 (Actual)
Sponsor	Assiut University (Other)
Conditions	Contraception
Interventions	lidocaine gel, placebo gel (Drug)
Dates	start 2017-09-01, primary completion 2020-03-31, completion 2020-05-31, first posted 2017-05-24, last updated 2020-10-06
Locations	1 site in Egypt

-Summary

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one. Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and prostaglandins has been reported with variable degrees of success .

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+Arms and interventions

Arm	Type	Interventions	Description
lidocaine group	Experimental	Drug: lidocaine gel	lidocaine in-situ gel inserted vaginally
placebo group	Placebo comparator	Drug: placebo gel	placebo gel inserted vaginally

lidocaine gel (Drug): syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion
placebo gel (Drug): syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion

+Outcome measures

Primary outcomes

The difference in pain scores during intrauterine device insertion [10 minutes]: using visual analog scale from 0 to 10

+Eligibility

Sex: Female, ages: 18 Years to 49 Years

Inclusion criteria:

* Non-pregnant women
* Women that did not receive any analgesics or misoprostol in the 24 hours prior to insertion
* Women who delivered only by caesarean section

Exclusion criteria:

* Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids
* Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
* Allergy to lidocaine.
* Women refuse to participate in the study

+Locations (1)

Facility	City	Country	Status
Assiut University	Asyut	Egypt

+Publications

Results publication: Abbas AM, Abd Ellah NH, Hosny MA, Abdellah MS, Ali MK. Self-administrated vaginal 2% lidocaine in-situ gel for pain relief during copper intrauterine device insertion in women with previous caesarean delivery only: a randomised, double-blind placebo-controlled trial. Eur J Contracept Reprod Health Care. 2021 Apr;26(2):132-138. doi: 10.1080/13625187.2020.1868427. Epub 2021 Feb 4. PMID 33539256

My Notes

Public

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