Pain Control for Intrauterine Device Placement Using Paracervical Block

October 10, 2019 updated by: Sheila Mody, University of California, San Diego

Pain Control for Intrauterine Device Placement: A Randomized Controlled Trial of Paracervical Block

Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Currently there are no proven effective methods for reduction of pain during and after placement of modern IUDs. Paracervical block pain may decrease this placement pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Modern IUDs are highly effective long acting reversible forms of contraception. The Mirena IUD is 99.8% effective and the Paragard copper IUD is 99.2% effective in preventing pregnancy. Fear of IUD placement can be a barrier to obtaining this highly effective form of birth control. The current standard of care for pain management during and after IUD placement is no medication, as randomized control trials published to date have limited data regarding use of medications to decrease pain. There has been one trial to suggest that the use of naproxen with 1% lidocaine paracervical block (PCB) compared to PCB alone may decrease pain after IUD placement in primarily nulliparous patients. However, this study was with the much wider and no longer available Dalkon Shield IUD. In addition, this study did not show any significant decrease in pain scores during IUD placement. Studies to evaluate effectiveness of ibuprofen and misoprostol have shown no significant decrease in pain scores during and after IUD insertion, although the majority of participants in these studies were multiparous. There is some suggestion that 2% lidocaine gel one minute prior to IUD insertion may have some decrease in pain, although this study was poorly designed.

Although there is no standard of care in regards to pain medication administration prior to IUD placement, providers often suggest paracervical prior IUD insertion among nulliparous women. Therefore the primary aim of this study is to determine whether a paracervical block (PCB) decreases pain associated with intrauterine device (IUD) placement compared to no paracervical block. We hypothesize that administration of a PCB of 20 mL 1% buffered lidocaine prior to IUD placement will decrease pain scores by at least 20mm on a visual analog scale at various time points during IUD placement when compared to no paracervical block.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • UCSD
      • San Diego, California, United States, 92109
        • Planned Parenthood Mission Bay Parker Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Nulliparous women
  • English or Spanish speaking
  • Present for intrauterine device placement for contraception or menorrhagia (in the case of Mirena IUD insertion).

Exclusion Criteria:

  • Pregnancy
  • Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)
  • If the patient has taken any pain medications within 6 hours of enrollment, including aspirin or other NSAIDs
  • Misoprostol administration within 24 hours of enrollment
  • History of prior IUD insertion
  • Known contraindications to IUD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paracervical Block (PCB)

Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.

Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.
Procedure: Paracervical Block (PCB)

Drug: 1% Lidocaine Hydrochloride

Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.

IUD placement then proceeds
Sham Comparator: No Paracervical Block (Sham PCB)

Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.

Subject then receives Sham paracervical block with capped needle. Provider then places IUD.
Procedure: No Paracervical Block (Sham PCB)

Drug: 1% Lidocaine Hydrochloride

Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.

IUD placement then proceeds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain With Intrauterine Device (IUD) Placement
Time Frame: Moment of IUD insertion
Distance (mm) from the left of the 100-mm visual analog scale (reflecting magnitude of pain) recorded at time of IUD Placement. Scale range is from 0mm (no pain) to 100mm (worst pain possible). A lower score (less pain) is considered a better outcome.
Moment of IUD insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Pain Scores for All Time Points
Time Frame: Anticipation of procedure through 5 minutes after IUD placement
Distance (mm) from the left of the 100-mm visual analog scale of pain at various time points. Scale range is 0mm (no pain) to 100mm (worst pain possible). Lower scores are considered better outcomes.
Anticipation of procedure through 5 minutes after IUD placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Sheila Mody, MD MPH, UCSD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 10, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 141025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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