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Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion

Primary Purpose

Pain, Acute, Anesthesia, Local, IUD Insertion Complication

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Anesthesia
Dry-needling
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring Intrauterine contraception, Pain, Anesthesia, LNG-IUD, nulligravida

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age between 18 and 45 years;
  • That were never pregnant before;
  • That wants to use LNG-IUD;
  • Not pregnant at the time of insertion;
  • No haematological disease;
  • That do not have signs and / or symptoms of vaginal / cervical infection.

Exclusion Criteria:

  • Categories 3 and / or 4 for the use of LNG-IUD according to the medical eligibility criteria of the World Health Organization (WHO), users of illicit drugs and / or alcohol, allergy or contraindication to lidocaine, presence of chronic pelvic pain of any etiology, presence of cervical abnormality such as isthmus-cervical fibrosis or incompetence, surgery on the cervix, psychiatric disorders, chronic use of medications that could interfere with the pain threshold (such as antidepressants and anticonvulsants).

Sites / Locations

  • University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Anesthesia

Dry-needling

No intervention

Arm Description

A 2% lidocaine without vasoconstrictor injection into the cervix

A placement of thin needle into the cervix without substance injection

No intervention for pain relief prior to LNG-IUS insertion

Outcomes

Primary Outcome Measures

Pain associated with LNG-IUS insertion using VAS
To evaluate pain scores using the visual analog scale (VAS)

Secondary Outcome Measures

Pain associated with LNG-IUS insertion using face scale
To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP)
Pain associated with tenaculum placement using VAS
To evaluate pain scores using the visual analog scale (VAS)
Pain associated with tenaculum placement using faces scale
To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP)
Ease of IUS insertion
To evaluate ease of LNG-IUS insertion rated by the provider

Full Information

First Posted
April 3, 2017
Last Updated
July 31, 2019
Sponsor
University of Sao Paulo
Collaborators
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT03111342
Brief Title
Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion
Official Title
Effect of Intracervical Anesthesia on Pain Associated With the Insertion of Levonorgestrel-releasing Intrauterine System in Nulligravida Women: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
University of Campinas, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of our study is to evaluate the effect of intracervical anesthesia on pain scores immediately following levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in nulligravida women.
Detailed Description
No prophylactic pharmacological intervention has proven efficacy in relieving pain during or after the insertion of levonorgestrel-releasing intrauterine system (LNG-IUS), only in reducing pain associated with the tenaculum. It is known that the nulligravida women have 3 times more chance of presenting moderate / severe pain associated to LNG-IUS placement. A previous study showed that injectable intracervical anesthesia reduced the risk of moderate/severe pain by 40%. However, the anesthetic dose was small (36 mg of lidocaine) and the study did not evaluate only nulligravida women which are potential candidates for most pain relief benefit. Thus, the primary aim of this study is to evaluate the effect of intracervical anesthesia on pain scores immediately following LNG-IUS insertion in nulligravida women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Anesthesia, Local, IUD Insertion Complication
Keywords
Intrauterine contraception, Pain, Anesthesia, LNG-IUD, nulligravida

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Nulligravida women will be block-randomized to one of three groups (intracervical anesthesia, intracervical dry needling or no intervention)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The care provider will open the randomization envelope and will do one of three possible approaches (a intracervical lidocaine injection, a intracervical dry needling or no intervention). Then, a second care provider will insert the intrauterine contraceptive (IUC) blinding for the approach of the first care provider. After IUC insertion, the latter care provider will assess the pain felt by the woman using proper scales. The woman will be also blinded to the approach used before IUC insertion.
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anesthesia
Arm Type
Experimental
Arm Description
A 2% lidocaine without vasoconstrictor injection into the cervix
Arm Title
Dry-needling
Arm Type
Sham Comparator
Arm Description
A placement of thin needle into the cervix without substance injection
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention for pain relief prior to LNG-IUS insertion
Intervention Type
Drug
Intervention Name(s)
Anesthesia
Other Intervention Name(s)
2% lidocaine without vasoconstritor
Intervention Description
A 2% lidocaine without vasoconstrictor injection into the cervix
Intervention Type
Procedure
Intervention Name(s)
Dry-needling
Intervention Description
A placement of thin needle into the cervix without substance injection
Primary Outcome Measure Information:
Title
Pain associated with LNG-IUS insertion using VAS
Description
To evaluate pain scores using the visual analog scale (VAS)
Time Frame
Immediately following LNG-IUS insertion
Secondary Outcome Measure Information:
Title
Pain associated with LNG-IUS insertion using face scale
Description
To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP)
Time Frame
Immediately following LNG-IUS insertion
Title
Pain associated with tenaculum placement using VAS
Description
To evaluate pain scores using the visual analog scale (VAS)
Time Frame
Immediately following tenaculum placement
Title
Pain associated with tenaculum placement using faces scale
Description
To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP)
Time Frame
Immediately following tenaculum placement
Title
Ease of IUS insertion
Description
To evaluate ease of LNG-IUS insertion rated by the provider
Time Frame
Immediately following LNG-IUS insertion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 18 and 45 years; That were never pregnant before; That wants to use LNG-IUD; Not pregnant at the time of insertion; No haematological disease; That do not have signs and / or symptoms of vaginal / cervical infection. Exclusion Criteria: Categories 3 and / or 4 for the use of LNG-IUD according to the medical eligibility criteria of the World Health Organization (WHO), users of illicit drugs and / or alcohol, allergy or contraindication to lidocaine, presence of chronic pelvic pain of any etiology, presence of cervical abnormality such as isthmus-cervical fibrosis or incompetence, surgery on the cervix, psychiatric disorders, chronic use of medications that could interfere with the pain threshold (such as antidepressants and anticonvulsants).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina S Vieira, MD, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
Ribeirão Preto
State/Province
SP
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The IPD will be collect using Redcap and will be kept in special file until analysis. Then, data will be summarized for analysis.

Learn more about this trial

Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion

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