Clinical trial NCT00613821: Lidocaine and Pain Management in First Trimester Abortions
Official title: A Comparison of Intrauterine Lidocaine Infusion and Paracervical Block for Pain Management in First Trimester Abortions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: surgical abortion
pain management
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine the effect of lidocaine (a numbing medication) inside the uterus on patient pain during an early abortion, compared to the paracervical block (lidocaine injected on either side of the cervix).

Detailed description: The Investigators intend to conduct a randomized, patient-blinded control trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette. Women will be approached about this study after they have made a decision to terminate the pregnancy. The women will be blinded and randomized into one of two study arms.

Group 1: the investigator will apply pressure with the capped needle of the paracervical block at the cervical-vaginal reflexion at 4 and 8 o'clock. This will approximate the steps involved in a paracervical block without injecting the patient. Following this, the patient will receive a 5 milliliter intrauterine infusion of 4% lidocaine using a sterile 3mm Novak curette. The infusion will be placed slowly over 3 minutes.

Group 2: a standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. Following this, a 3 mm Novak curette will be placed in the vagina and held to the external os of the cervix for 3 minutes. The curette will not be placed through the cervix and no infusion will be performed. This will approximate the steps involved in an intrauterine infusion without injecting the patient.

During the procedure, women in both groups will be asked to rate their pain at various times using a 10 cm visual analog scale (VAS).

Eligibility criteria: Inclusion Criteria:

* Good general health
* Age\>18years
* English speaking
* Voluntarily requesting pregnancy termination
* Have an estimated gestation of up to 76 days since the first day of the preceding menstrual period
* Confirmed by ultrasound
* Be able and willing to sign an informed consent
* Agree to the terms of the study
* All patients must be premedicated with Ibuprofen and Valium (per clinic protocols)

Exclusion Criteria:

* Significant physical or mental health condition
* A gestational age of 77 days or more
* Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease
* Patients who require or request IV/intramuscular sedation
* Patients who refuse Ibuprofen, Valium and/or paracervical blocks
* Patients allergic to lidocaine
* Patients with known hepatic disease
* Patients weighing less than 100 lbs

Primary outcomes:
measure: The Effects of an Intrauterine Lidocaine Infusion to Standard Paracervical Block on Decreasing Patient Pain Measured by Visual Analog Scale in First Trimester Abortions.
timeFrame: Immediately (time zero) at uterine aspiration
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Planned Parenthood of the Columbia Willamette
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alison Edelman, M.D., M.P.H
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edelman A, Nichols MD, Leclair C, Jensen JT. Four percent intrauterine lidocaine infusion for pain management in first-trimester abortions. Obstet Gynecol. 2006 Feb;107(2 Pt 1):269-75. doi: 10.1097/01.AOG.0000194204.71925.4a.