Paracervical Block Versus No Paracervical Block During IUD Insertion

Phase 4

Completed

• Conditions: Analgesia; IUD Insertion
• Interventions: Other: No analgesia; Drug: Lidocaine; Device: Intrauterine device (IUD)

• Registration Number: NCT02904915
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The purpose of this study is to compare the pain level and level of discomfort with paracervical block versus no analgesia in women who present to the University of Texas (UT) Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Study Start: 2017-01-12
• Primary Completion: 2017-10-09
• Study Completion: 2017-10-09
• Status Verified: 2018-10
• Results First Submitted: 2018-10-09
• Results First Submitted QC: 2018-10-09
• Last Update Submitted: 2018-10-09
• Results First Posted: 2018-11-07
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Women of reproductive age who present for an IUD insertion procedure at the University of Texas Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.

Exclusion Criteria

• Women with current pelvic inflammatory disease (PID)
• Women who are not good candidates for an IUD
• Patients who have a Lidocaine allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracervical block	Intrauterine device (IUD)	Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.
No analgesia	No analgesia	IUD placement with no analgesia.
No analgesia	Intrauterine device (IUD)	IUD placement with no analgesia.
Paracervical block	Lidocaine	Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.

Primary Outcome Measures

Name	Time	Method
Pain Score as Assessed by a Visual Analogue Scale (VAS)	baseline (about 30 seconds after insertion of the speculum)	The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD).; The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine).
Pain Score as Assessed by a Visual Analogue Scale	about 30 seconds after insertion of the IUD (IUD inserted about 4 to 5 minutes after insertion of tenaculum)	The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD).; The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine).

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States