Study of Local Anesthesia as a Method to Decrease IUD Insertion Related Pain

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Roxanne Jamshidi, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01967017
First received: December 11, 2012
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

Despite the high efficacy of intrauterine devices (IUDs), some women choose not to receive IUDs secondary to the pain associated with insertion. Nulliparous women may be especially susceptible to procedure-related pain from IUD insertion. This study will investigate the difference in perceived pain from IUD insertion, comparing local anesthesia to a placebo, among women who have not had a vaginal delivery before. The investigators anticipate that among women who have not had a previous vaginal delivery, the pain associated with IUD insertion will be significantly decreased after administration of local anesthesia.


Condition Intervention Phase
IUD Insertion Complication
Pain Control
Drug: Lidocaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paracervical Block With Lidocaine as a Modality to Decrease IUD Insertion Related Pain

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Pain at time of IUD insertion [ Time Frame: During IUD insertion (no further follow up after patient leaves ofice) ] [ Designated as safety issue: No ]
    Differences in visual analog scale (VAS) measurements of perceived pain at the time of IUD deployment


Secondary Outcome Measures:
  • Pain at other time points of pelvic exam [ Time Frame: During other steps of pelvic exam up to 15b minutes after IUD inserted (no further follow up after patient leaves office) ] [ Designated as safety issue: No ]
    Intrapersonal and group differences in VAS measurements of expected pain and other time points


Other Outcome Measures:
  • Ease of insertion [ Time Frame: Within 15 minutes of IUD insertion ] [ Designated as safety issue: No ]
    The degree of difficulty of insertion as rated by the provider will be compared between groups.


Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine
Paracervical block using 15 mL of 1 % lidocaine
Drug: Lidocaine
Placebo Comparator: Placebo
paracervical block using 15 mL of bacteriostatic saline

Detailed Description:

The study will investigate the difference in perceived pain from IUD insertion, comparing paracervical block with lidocaine to a placebo (bacteriostatic saline) block, among nulliparous and "functionally nulliparous" women. The investigators plan a double-masked, placebo controlled, randomized clinical trial. The investigators anticipate that among patients who have not had a previous vaginal delivery, the pain associated with IUD insertion will be significantly decreased after administration of a 15 mL 1% lidocaine paracervical block compared to patients who receive 15 mL of bacteriostatic saline (placebo).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Nulliparous and "functionally nulliparous" women receiving their first IUD. "Functionally nulliparous" women include those who have never had a prior vaginal delivery or who have never experienced previous significant cervical dilation (ie. women who have experienced miscarriages or abortions prior to 24 weeks gestation, and women who have had cesarean sections while not in active labor defined as <4 cm dilation).
  • English speaking

Exclusion Criteria:

  • Presence of a Centers for Disease Control Medical Eligibility Criteria for Contraceptive Use category 3 or 4 precaution to a levonorgestrel IUD
  • chronic narcotic use, current or past history of illegal drug use (excluding marijuana)
  • allergy to lidocaine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967017

Contacts
Contact: Roxanne Jamshidi, MD 410-550-0336 rjamshi1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21224
Contact: Nell Molano, CRNP    410-874-1455      
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Roxanne Jamshidi, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01967017     History of Changes
Other Study ID Numbers: NA_00078756
Study First Received: December 11, 2012
Last Updated: October 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Intrauterine device
Paracervical block

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014