Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion

NCT03111342 | Completed Phase 4

• 1 other identifier: Pain LNG-IUS
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Anesthesia, Local; IUD Insertion Complication

Keywords

Intrauterine contraception; Pain; Anesthesia; LNG-IUD; nulligravida

Outcome Measures

Primary Outcomes (1)

• Pain associated with LNG-IUS insertion using VAS

  To evaluate pain scores using the visual analog scale (VAS)

  Immediately following LNG-IUS insertion

Secondary Outcomes (4)

• Pain associated with LNG-IUS insertion using face scale

  Immediately following LNG-IUS insertion

• Pain associated with tenaculum placement using VAS

  Immediately following tenaculum placement

• Pain associated with tenaculum placement using faces scale

  Immediately following tenaculum placement

• Ease of IUS insertion

  Immediately following LNG-IUS insertion

Study Arms (3)

Anesthesia

EXPERIMENTAL

A 2% lidocaine without vasoconstrictor injection into the cervix

Drug: Anesthesia

Dry-needling

SHAM COMPARATOR

A placement of thin needle into the cervix without substance injection

Procedure: Dry-needling

No intervention

NO INTERVENTION

No intervention for pain relief prior to LNG-IUS insertion

Interventions

Anesthesia DRUG

A 2% lidocaine without vasoconstrictor injection into the cervix

Also known as: 2% lidocaine without vasoconstritor

Anesthesia

Dry-needling PROCEDURE

A placement of thin needle into the cervix without substance injection

Dry-needling

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Sao Paulo: lead
• University of Campinas, Brazil: collaborator

Study Sites (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

MeSH Terms

Conditions

Acute Pain; Pain

Interventions

Anesthesia; Lidocaine; Dry Needling

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Carolina S Vieira, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Nulligravida women will be block-randomized to one of three groups (intracervical anesthesia, intracervical dry needling or no intervention)

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 12, 2017
• Study Start: June 1, 2017
• Primary Completion: August 30, 2018
• Study Completion: August 31, 2018
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

BR (1)