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Lidocaine In-situ Gel Before Intrauterine Device Insertion

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT02943135
Collaborator
(none)
120
Enrollment
2
Locations
2
Arms
29.9
Actual Duration (Months)
60
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Intrauterine device can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the insertion tube, and removing the tube; and placement of the device in the uterus.

Condition or Disease Intervention/Treatment Phase
  • Drug: lidocaine in-situ gel
  • Drug: placebo in-situ gel
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Effect of Self-administered Lidocaine In-situ Gel on Intrauterine Device Insertion Pain: A Randomized Controlled Trial
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Mar 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: lidocaine in-situ

Self-administered gel 10 min before intrauterine device insertion

Drug: lidocaine in-situ gel
lidocaine in-situ gel
Placebo Comparator: placebo

Self-administered gel 10 min before intrauterine device insertion

Drug: placebo in-situ gel
placebo in-situ gel

Outcome Measures

Primary Outcome Measures

  1. Mean pain score during intrauterine device insertion [30 min]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Women not taken analgesics or anxiolytics in the 24 hours prior insertion

  • Women not taken misoprostol prior to insertion

  • No contraindication to or history of allergic reaction to lidocaine

  • Women who will accept to participate in the study

Exclusion Criteria:

  • Lidocaine allergy

  • Any contraindication to device placement

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ahmed Abbas Assiut Cairo Egypt 002
2 Assiut University Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Mohamed Abbas, Dr, Assiut University
ClinicalTrials.gov Identifier:
NCT02943135
Other Study ID Numbers:
  • LISID
First Posted:
Oct 24, 2016
Last Update Posted:
May 20, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lidocaine

Study Results

No Results Posted as of May 20, 2020