A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion

• Sponsor: Women and Infants Hospital of Rhode Island (Other)
• Overall Status: Completed
• CT.gov ID: NCT01292447
• Collaborator: Society of Family Planning (Other)
• Enrollment: 150
• Locations: 2
• Arms: 2
• Duration (Months): 24
• Patients Per Site: 75
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. In fact, no interventions evaluated in randomized controlled trials have been shown to be effective in reducing pain during IUD insertion. While many women tolerate IUD insertion well, others have moderate to severe pain. This double-blind randomized controlled trial of 150 women aims to estimate the efficacy of intracervical 2% lidocaine gel compared to placebo (KY jelly) to reduce IUD insertion pain. Our hypothesis is that women who are treated with 2% lidocaine gel prior to IUD insertion will have reduced pain as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). We will be able to detect a 15 mm difference on the VAS with our sample size. Other data to be collected include information regarding age, BMI, obstetric history, lactation status, time since pregnancy or delivery, last menstrual period, history of cervical conization, anxiety levels, anticipated pain levels, insertion characteristics (time, difficulty, complications), side effects, and satisfaction with pain control. If 2% lidocaine gel is effective, then a viable, easily administered option for pain control will be available to providers and patients.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: 2% lidocaine gel; Drug: Placebo gel	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: A Randomized Controlled Trial of 2% Lidocaine Gel for IUD Insertion
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Group Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement.	Drug: Placebo gel; Inert gel x 1
Experimental: Study Group Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement.	Drug: 2% lidocaine gel; 120mg lidocaine x 1

Outcome Measures

Primary Outcome Measures

1. Mean Pain Score During IUD Insertion [Day 1]

   0 to 100 mm visual analog scale, higher values represent more pain.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. plans for IUD insertion for contraception or abnormal uterine bleeding;

2. 18 to 49 years of age;

3. reached more than 6 weeks postpartum or 2 weeks postabortion if recently pregnant;

4. no prior IUD use;

5. not taken analgesics or anxiolytics in the previous 24 hours;

6. not taken misoprostol prior to IUD insertion;

7. the ability and are willing to give informed consent;

8. speaks English or Spanish.

Exclusion Criteria:

1. any contraindication to IUD placement;

2. allergy to lidocaine or sensitivities to components of the lidocaine or placebo gel;

3. chronic narcotic/benzodiazepine/barbiturate use within the past year.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women's Primary Care Center/Women and Infants' Hospital	Providence	Rhode Island	United States	02905
2	Womens Primary Care Center	Providence	Rhode Island	United States	02905

Sponsors and Collaborators

• Women and Infants Hospital of Rhode Island
• Society of Family Planning

Investigators

• Principal Investigator: Rebecca H Allen, MD, MPH, Women and Infants Hospital of Rhode Island

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rebecca H. Allen, MD, Assistant Professor ob/gyn, Women and Infants Hospital of Rhode Island
• ClinicalTrials.gov Identifier: NCT01292447
• Other Study ID Numbers: 10-0084
• First Posted: Feb 9, 2011
• Last Update Posted: Sep 2, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by Rebecca H. Allen, MD, Assistant Professor ob/gyn, Women and Infants Hospital of Rhode Island: Pain measurement; Intrauterine devices; Lidocaine
• Additional relevant MeSH terms: Lidocaine

Study Results

Participant Flow

Arm/Group Title	Control Group	Study Group
Arm/Group Description	Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement. Placebo gel: Inert gel x 1	Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement. 2% lidocaine gel: 120mg lidocaine x 1
Period Title: Overall Study
STARTED	75	75
COMPLETED	73	72
NOT COMPLETED	2	3

Baseline Characteristics

Arm/Group Title	Control Group	Study Group	Total
Arm/Group Description	Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement. Placebo gel: Inert gel x 1	Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement. 2% lidocaine gel: 120mg lidocaine x 1	Total of all reporting groups
Overall Participants	73	72	145
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.2 (5)	26.2 (5.3)	25.7 (5)
Sex: Female, Male (Count of Participants)
Female	73 100%	72 100%	145 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Mean Pain Score During IUD Insertion
Description	0 to 100 mm visual analog scale, higher values represent more pain.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Study Group
Arm/Group Description	Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement. Placebo gel: Inert gel x 1	Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement. 2% lidocaine gel: 120mg lidocaine x 1
Measure Participants	73	72
Mean (Standard Deviation) [score on a scale]	36.7 (30)	35.2 (27.7)

Adverse Events

Arm/Group Title	Control Group		Study Group
Arm/Group Description	Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement. Placebo gel: Inert gel x 1		Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement. 2% lidocaine gel: 120mg lidocaine x 1
All Cause Mortality
	Control Group		Study Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Group		Study Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/73 (0%)		0/72 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		Study Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/73 (1.4%)		1/72 (1.4%)
Surgical and medical procedures
Acute complication	1/73 (1.4%)	1	1/72 (1.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.