Intrauterine Lidocaine Infusion for Essure Sterilization Procedures

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Lidocaine; Drug: Sterile Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00613834

OHSU FAMPLAN 3343

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

58 participants in 2 patient groups, including a placebo group

Lidocaine group

Experimental group

Description:

Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization

Treatment:

Drug: Lidocaine

Control group

Placebo Comparator group

Description:

Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization

Treatment:

Drug: Sterile Saline