Transdermal Lidocaine Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System

NCT04517890 | Unknown DMC

• 1 other identifier: aswu/297/3/19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

aims to investigate the effectiveness of Transdermal lidocaine patch for Pain Control During Levonorgestrel Releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section

Conditions

IUCD Complication

Outcome Measures

Primary Outcomes (1)

• The difference in pain scores during intrauterine device insertion

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

  10 minutes

Secondary Outcomes (1)

• duration of IUD insertion

  15 minutes

Study Arms (2)

lidocaine patch

EXPERIMENTAL

5% lidocaine patch applied at 3 hours before the procedure

Drug: lidocaine patch

Sham patch

PLACEBO COMPARATOR

Sham patch containing no study medication applied 3 hours before the procedure

Drug: Sham patch

Interventions

lidocaine patch DRUG

5% lidocaine patch applied at 3 hours before the procedure

Also known as: Experimental

lidocaine patch

Sham patch DRUG

Sham patch containing no study medication applied 3 hours before the procedure

Also known as: Placebo Comparator

Sham patch

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Non-pregnant women who delivered only by cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

RECRUITING

Study Officials

• nahla w Shady, md

  Aswan universirty

  STUDY CHAIR

Central Study Contacts

hany f Sallam, md

CONTACT

+20102435461; hany.farouk@aswu.edu.eg

nahla w Shady, md

CONTACT

+201022336052; hanygyne@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind randomized controlled trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A Professor

Model Details: double blind randomized controlled trial

Study Record Dates

• First Submitted: August 15, 2020
• First Posted: August 19, 2020
• Study Start: September 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: September 1, 2021
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)