Pain
Conditions
Keywords
Essure sterilization, pain management, intrauterine lidocaine infusion
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.
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.
Interventions
DRUGLidocaine
5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes
DRUGSterile Saline
5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine Group Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization | 29 |
| Saline Group Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization | 29 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Saline Group | Lidocaine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 29 Participants | 58 Participants |
| Age, Continuous | 33.8 years STANDARD_DEVIATION 6.3 | 33.4 years STANDARD_DEVIATION 6.6 | 33.6 years STANDARD_DEVIATION 6.4 |
| Region of Enrollment United States | 29 participants | 29 participants | 58 participants |
| Sex: Female, Male Female | 29 Participants | 29 Participants | 58 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Primary
Change in Patient-perceived Pain Between Baseline and 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.
Time frame: Immediately after speculum insertion and immediately after cannulization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lidocaine Group | Change in Patient-perceived Pain Between Baseline and Cannulization | 29.5 score on a scale |
| Saline Group | Change in Patient-perceived Pain Between Baseline and Cannulization | 35 score on a scale |
Secondary
Patient Perceived Pain 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.
Time frame: 30 minutes post-procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lidocaine Group | Patient Perceived Pain 30 Minutes Post-procedure | 20 score on a scale |
| Saline Group | Patient Perceived Pain 30 Minutes Post-procedure | 32.5 score on a scale |
Secondary
Patient Satisfaction With the Essure Tubal Sterilization 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.
Time frame: 30 minutes post-procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lidocaine Group | Patient Satisfaction With the Essure Tubal Sterilization Procedure | 94 score on a scale |
| Saline Group | Patient Satisfaction With the Essure Tubal Sterilization Procedure | 93.5 score on a scale |