The Impact of Pain Scores on Intrauterine Lidocaine Versus Normal Saline Infusion at the Time of IUD Placement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anita Nelson, Women's Health Care Clinic, Torrance, California
ClinicalTrials.gov Identifier:
NCT01311102
First received: June 21, 2010
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

The study hypothesis is that infusion of 2% lidocaine at the time of IUD placement will reduce pain scores related to that procedure. In a double blinded randomized trial of 60 women receiving either normal saline or lidocaine infused through an endometrial aspirator, pain scores will be obtained for each step of the IUD placement procedure and for the total experience.


Condition Intervention Phase
Pain
Drug: Lidocaine
Drug: Normal Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind, Randomized, Prospective Trial of Impact of Pain Scores on Intrauterine Lidocaine vs Normal Saline Infusion Before IUD Placement.

Resource links provided by NLM:


Further study details as provided by Women's Health Care Clinic, Torrance, California:

Primary Outcome Measures:
  • Pain Scores During Overall IUD Placement [ Time Frame: Before patient left the examination room at conclusion of procedure ] [ Designated as safety issue: No ]
    Pain score on 0-9 scale obtained just before the patient left the examination room; with 0 being "no pain" and 9 being "worst pain in life."

  • Pain During Tenaculum Placement [ Time Frame: Immediately following tenaculum placement ] [ Designated as safety issue: No ]
    Pain score on 0-9 scale for tenaculum placement (without anesthesia); with 0 being "no pain" and 9 being "worst pain in life." Taken to adjust for different pain thresholds among subjects

  • Pain Measurement During Liquid Infusion/Sounding [ Time Frame: Recorded at the end of the infusion ] [ Designated as safety issue: No ]
    After liquid infused into three parts of the endometrial cavity: in the lower one third, the middle, and at the top of the cavity. Pain was scored on a 0-9 scale; with 0 being "no pain" and 9 being "worst pain in life."

  • Pain During IUD Placement [ Time Frame: Immediately after IUD placement ] [ Designated as safety issue: No ]
    IUD was inserted following the manufacturer's instructions, and a pain score was immediately obtained. Pain was scored on 0-9 scale; with 0 being "no pain" and 9 being "worst pain in life."


Enrollment: 40
Study Start Date: July 2008
Study Completion Date: December 2012
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2% Lidocaine liquid
1.33cc of 2% liquid lidocaine infused in endo cervix and endometrium
Drug: Lidocaine
1.33 cc 2% liquid lidocaine
Other Names:
  • Lidocaine Hydrochloride
  • Xylocaine
Placebo Comparator: Normal Saline
1.33cc of normal saline infused in endo cervix and endometrium
Drug: Normal Saline
1.33cc normal saline
Other Name: Sodium chloride

Detailed Description:

IUDs are the most frequently used method of reversible birth control. The placement procedure is straightforward, but can cause the women cramping and pain. Every woman is advised to take Ibuprofen or acetaminophen prior to her appointment. Gentle techniques and distraction are used to minimize discomfort. However, some women still have measurable pain during and immediately after the procedure.

Investigators have shown that infusion of 5cc of a 2% concentration of liquid lidocaine into the inside of the uterus can reduce the pain that is associated with other procedures, such as biopsies done of the lining of the uterus. The investigators seek to determine if a similar infusion made before IUD placement may reduce pain. Because pain is a subjective complaint and because plastic tubing is being used to sound the uterus instead of the usual metal probe (a uterine sound), the investigators have included a placebo arm with saline infusion. All women will receive oral medication in advance of IUD placement, so no woman will be subject to placebo only.

Those women undergoing routine screening for IUD candidacy will be approached. Medical and social history and routine laboratory testing are to be done. The risks, benefits, and side effects of IUD placement will be explained. They will sign consent forms for the IUD from both the manufacturer and the clinic before evaluation for possible inclusion in this study. Informed consent for the study will be obtained either at that visit or on the day of the IUD placement. All the routine IUD placement steps will be done and she will rate the pain score. A standardized pain scale from 1-10, with 10 being the worst pain in the patient's lifetime, will be used here and at every point in the study. Depth of the uterus will be determined by introducing a plastic tubing into the woman's uterus. This tubing will either be filled with 1.3cc of normal saline or 2% lidocaine. The liquid will be infused at certain points within the cervix and uterus. She will again be asked to rate her pain score for that procedure. The tubing will be removed and the IUD will be placed. After the IUD is in the correct position, but before removal of the tenaculum, she will again be asked to rate her pain score for that procedure. After the IUD placement procedure is complete and the patient is dressed, she will be asked to assign an overall pain score. Pain scores between placebo and study drug used will be compared (mean, median and range). Fisher T tests will be performed to determine statistical significance with the p< 0.05 as a cutoff. Sub-analysis will be done comparing scores of which women who have never been pregnant to those who have. If possible, comparisons of pain scores will be made for women who have had vaginal deliveries compared to those who delivered by C-section. The risks to the patient for this study intervention are minimal.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women eligible for IUD insertion
  • Willing to give consent

Exclusion Criteria:

  • Allergy to lidocaine
  • Contraindications to IUD use
  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: NCT01311102

Locations
United States, California
Women's Health Care Clinic
Torrance, California, United States, 90502
Sponsors and Collaborators
Women's Health Care Clinic, Torrance, California
Investigators
Principal Investigator: Anita L Nelson, M.D. Women's Health Care Clinic
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anita Nelson, Medical Director, Women's Health Care Clinic, Torrance, California
ClinicalTrials.gov Identifier: NCT01311102     History of Changes
Other Study ID Numbers: 13531-01
Study First Received: June 21, 2010
Results First Received: October 14, 2013
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Women's Health Care Clinic, Torrance, California:
Pain score
IUD placement

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

ClinicalTrials.gov processed this record on July 22, 2014