Intrauterine Lidocaine Infusion for Essure Sterilization Procedures
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Purpose
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 | Intervention |
|---|---|
|
Pain |
Drug: Lidocaine Drug: Sterile Saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Intrauterine Lidocaine Infusion for Pain Management During Outpatient Essure Transcervical Tubal Sterilization Procedures |
- Intrauterine lidocaine and patient perceived pain with Essure tubal sterilization as compared to the standard paracervical block. [ Time Frame: After enrollment is complete ] [ Designated as safety issue: No ]
- To measure the amount of pain experienced during outpatient Essure procedures in the placebo group. [ Time Frame: After enrollment is complete ] [ Designated as safety issue: No ]
- To determine whether intrauterine lidocaine results in greater satisfaction with the Essure tubal sterilization experience. [ Time Frame: After enrollment is complete ] [ Designated as safety issue: No ]
- To obtain safety data on the absorption of intrauterine lidocaine in the non-pregnant uterus. [ Time Frame: After enrollment is complete ] [ Designated as safety issue: Yes ]
| Enrollment: | 58 |
| Study Start Date: | May 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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
|
| Placebo Comparator: 2 |
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
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| Planned Parenthood of the Columbia Willamette | |
| Portland, Oregon, United States, 97206 | |
| Principal Investigator: | Michelle M. Isley, M.D. | Oregon Health and Science University |
More Information
Additional Information:
No publications provided by Oregon Health and Science University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Michelle Isley, MD, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT00613834 History of Changes |
| Other Study ID Numbers: | OHSU FAMPLAN 3343 |
| Study First Received: | January 31, 2008 |
| Last Updated: | February 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Oregon Health and Science University:
|
Essure sterilization pain management intrauterine lidocaine infusion |
Additional relevant MeSH terms:
|
Lidocaine Disinfectants 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 Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 21, 2013