Intrauterine Lidocaine Infusion for Essure Sterilization Procedures

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00613834
• Collaborator: (none)
• Enrollment: 58
• Locations: 2
• Arms: 2
• Duration (Months): 13
• Patients Per Site: 29
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the level of pain women experience with an Essure procedure and the effect that lidocaine might have on that pain. We will also assess the absorption of lidocaine in the uterus by measuring lidocaine levels in the blood.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Lidocaine; Drug: Sterile Saline	Phase 4

Detailed Description

We intend to conduct a randomized, blinded, and placebo- controlled clinical trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette to determine if intrauterine lidocaine infusion will decrease the amount of pain subjects experience during and after Essure transcervical tubal sterilization.

We plan to enroll women who have selected Essure as their method of tubal sterilization who will be randomized to one of two groups on the days of their procedures. Subjects in Group 1, the treatment group, will receive a standard paracervical block with lidocaine intrauterine infusion and subjects in Group 2, the control group, will receive a standard paracervical block with saline intrauterine infusion. The subjects will be asked to rate their pain on a 100 mm Visual Analog Scale (VAS) at five points during the procedure and once thirty minutes following the procedure. Subjects will also be asked to rate their overall satisfaction with their care prior to leaving the recovery room.

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Intrauterine Lidocaine Infusion for Pain Management During Outpatient Essure Transcervical Tubal Sterilization Procedures
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lidocaine group Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization	Drug: Lidocaine; 5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes; Other Names: Xylocaine
Placebo Comparator: Control group Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization	Drug: Sterile Saline; 5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes

Outcome Measures

Primary Outcome Measures

1. Change in Patient-perceived Pain Between Baseline and Cannulization [Immediately after speculum insertion and immediately after cannulization]

   Patients rated their pain following speculum insertion (used as baseline) and after insertion of a cannula into both fallopian tubes. Reported pain during cannulization of the right and left fallopian tubes were averaged to obtain the measurement of pain at cannulization. Pain was reported using a Visual Analog Scale (VAS, range 0-100), where a score of 0 indicates no pain and a score of 100 indicates the worst pain imaginable. Baseline pain levels were subtracted from average pain during cannulization: a negative change in VAS score between baseline and cannulization indicates less pain during cannulization and a positive change in VAS score indicates more pain during cannulization.

Secondary Outcome Measures

1. Patient Perceived Pain 30 Minutes Post-procedure [30 minutes post-procedure]

   Patients rated their pain 30 minutes after speculum removal using a Visual Analog Scale (VAS, range 0-100), where a score of 0 indicates no pain and a score of 100 indicates the worst pain imaginable.

2. Patient Satisfaction With the Essure Tubal Sterilization Procedure [30 minutes post-procedure]

   Patients reported their overall satisfaction with the Essure tubal sterilization procedure using a Visual Analog scale (VAS), range 0-100. A score of 0 indicates lowest possible satisfaction and a score of 100 indicates highest possible satisfaction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Female

• Age 18 or older

• Good general health, based on the opinion of the investigator

• Voluntarily requesting permanent sterilization

• Negative pregnancy test

• Agree to premedication with ibuprofen and ativan

• English speaking, or other language if an interpreter is available to be present at all points of the study procedure.

• Willing and able to sign an informed consent

• Willing to comply with the terms of the study

Exclusion Criteria:

• Significant physical or mental health condition, based on the opinion of the investigator.

• Positive pregnancy test

• Request for IV/IM sedation prior to the start of the procedure

• Refusal of ibuprofen, ativan, or paracervical block

• Allergy to any study medication including lidocaine, ibuprofen, ativan, sodium bicarbonate

• History of toxic reaction to local anesthetics

• Known hepatic disease or liver dysfunction. (Lidocaine is metabolized by the liver.)

• Weight less than 100 pounds. [Any patient weighing less than 100 pounds would receive more than the recommended dose for their weight (4.5 mg/kg or 2 mg/lb)].

• Current participation in another research study which would interfere with the conduct of this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Planned Parenthood of the Columbia Willamette	Portland	Oregon	United States	97206
2	Oregon Health & Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

• Oregon Health and Science University

Investigators

• Principal Investigator: Michelle M. Isley, M.D., Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• (Women's Health Research Unit website)

Publications

None provided.

• Responsible Party: Alison Edelman, Principal Investigator, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT00613834
• Other Study ID Numbers: OHSU FAMPLAN 3343
• First Posted: Feb 13, 2008
• Last Update Posted: Dec 19, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Alison Edelman, Principal Investigator, Oregon Health and Science University: Essure sterilization; pain management; intrauterine lidocaine infusion
• Additional relevant MeSH terms: Lidocaine

Study Results

Participant Flow

Arm/Group Title	Lidocaine Group	Saline Group
Arm/Group Description	Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization	Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
Period Title: Overall Study
STARTED	29	29
COMPLETED	29	26
NOT COMPLETED	0	3

Baseline Characteristics

Arm/Group Title	Lidocaine Group	Saline Group	Total
Arm/Group Description	Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization	Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization	Total of all reporting groups
Overall Participants	29	29	58
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	29 100%	29 100%	58 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.4 (6.6)	33.8 (6.3)	33.6 (6.4)
Sex: Female, Male (Count of Participants)
Female	29 100%	29 100%	58 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	29 100%	29 100%	58 100%

Outcome Measures

1. Primary Outcome

Title	Change in Patient-perceived Pain Between Baseline and Cannulization
Description	Patients rated their pain following speculum insertion (used as baseline) and after insertion of a cannula into both fallopian tubes. Reported pain during cannulization of the right and left fallopian tubes were averaged to obtain the measurement of pain at cannulization. Pain was reported using a Visual Analog Scale (VAS, range 0-100), where a score of 0 indicates no pain and a score of 100 indicates the worst pain imaginable. Baseline pain levels were subtracted from average pain during cannulization: a negative change in VAS score between baseline and cannulization indicates less pain during cannulization and a positive change in VAS score indicates more pain during cannulization.
Time Frame	Immediately after speculum insertion and immediately after cannulization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine Group	Saline Group
Arm/Group Description	Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization	Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
Measure Participants	29	26
Median (Full Range) [score on a scale]	29.5	35

2. Secondary Outcome

Title	Patient Perceived Pain 30 Minutes Post-procedure
Description	Patients rated their pain 30 minutes after speculum removal using a Visual Analog Scale (VAS, range 0-100), where a score of 0 indicates no pain and a score of 100 indicates the worst pain imaginable.
Time Frame	30 minutes post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine Group	Control Group
Arm/Group Description	Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization Lidocaine: 5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes	Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization Sterile Saline: 5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes
Measure Participants	29	26
Median (Full Range) [score on a scale]	20	32.5

3. Secondary Outcome

Title	Patient Satisfaction With the Essure Tubal Sterilization Procedure
Description	Patients reported their overall satisfaction with the Essure tubal sterilization procedure using a Visual Analog scale (VAS), range 0-100. A score of 0 indicates lowest possible satisfaction and a score of 100 indicates highest possible satisfaction.
Time Frame	30 minutes post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine Group	Saline Group
Arm/Group Description	Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization	Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
Measure Participants	29	29
Median (Full Range) [score on a scale]	94	93.5

Adverse Events

Time Frame	From enrollment to 30 minutes post-procedure
Arm/Group Title	Lidocaine Group		Saline Group
Arm/Group Description	Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization		Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
All Cause Mortality
	Lidocaine Group		Saline Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)
Serious Adverse Events
	Lidocaine Group		Saline Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Lidocaine Group		Saline Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)

Limitations/Caveats

Difference in reported abortions between the two groups. Data not included on three subjects in saline group because the subjects could not tolerate the procedure.

More Information

Certain Agreements

Principal Investigators are NOT 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.