Trial Outcomes & Findings for Intrauterine Lidocaine Infusion for Essure Sterilization Procedures (NCT NCT00613834)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

58 participants

Primary outcome timeframe

Immediately after speculum insertion and immediately after cannulization

Results posted on

2019-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Lidocaine Group Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization	Saline Group Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
Overall Study STARTED	29	29
Overall Study COMPLETED	29	26
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Lidocaine Group Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization	Saline Group Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Intrauterine Lidocaine Infusion for Essure Sterilization Procedures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine Group n=29 Participants Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization	Saline Group n=29 Participants Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33.4 years STANDARD_DEVIATION 6.6 • n=5 Participants	33.8 years STANDARD_DEVIATION 6.3 • n=7 Participants	33.6 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lidocaine Group n=29 Participants 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	Saline Group n=26 Participants Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
Change in Patient-perceived Pain Between Baseline and Cannulization	29.5 score on a scale Interval -7.0 to 73.0	35 score on a scale Interval -18.5 to 82.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lidocaine Group n=29 Participants 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	Saline Group n=26 Participants Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
Patient Perceived Pain 30 Minutes Post-procedure	20 score on a scale Interval 1.0 to 76.0	32.5 score on a scale Interval 0.0 to 97.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lidocaine Group n=29 Participants 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	Saline Group n=29 Participants Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
Patient Satisfaction With the Essure Tubal Sterilization Procedure	94 score on a scale Interval 46.0 to 100.0	93.5 score on a scale Interval 66.0 to 99.0

Adverse Events

Lidocaine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michelle Isley

The Ohio State University

Phone: 614-293-4203

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place