Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion

Effect of Intracervical Anesthesia on Pain Associated With the Insertion of Levonorgestrel-releasing Intrauterine System in Nulligravida Women: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Pain, Acute; IUD Insertion Complication
• Intervention / Treatment: Drug: Anesthesia; Procedure: Dry-needling

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Ribeirão Preto, SP, Brazil, 14049-900
      • University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Anesthesia; A 2% lidocaine without vasoconstrictor injection into the cervix	Drug: Anesthesia; A 2% lidocaine without vasoconstrictor injection into the cervix; Other Names: 2% lidocaine without vasoconstritor
SHAM_COMPARATOR: Dry-needling; A placement of thin needle into the cervix without substance injection	Procedure: Dry-needling; A placement of thin needle into the cervix without substance injection
NO_INTERVENTION: No intervention; No intervention for pain relief prior to LNG-IUS insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain associated with LNG-IUS insertion using VAS	To evaluate pain scores using the visual analog scale (VAS)	Immediately following LNG-IUS insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Immediately following LNG-IUS insertion
Pain associated with tenaculum placement using VAS	To evaluate pain scores using the visual analog scale (VAS)	Immediately following tenaculum placement
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)	Immediately following tenaculum placement
Ease of IUS insertion	To evaluate ease of LNG-IUS insertion rated by the provider	Immediately following LNG-IUS insertion

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: University of Campinas, Brazil

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): August 30, 2018
• Study Completion (ACTUAL): August 31, 2018

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (ACTUAL): April 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Pain; Anesthesia; Intrauterine contraception; LNG-IUD; nulligravida
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Pain LNG-IUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• 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