Lidocaine and Pain Management in First Trimester Abortions

Pain Clinical Trial

Official title:

A Comparison of Intrauterine Lidocaine Infusion and Paracervical Block for Pain Management in First Trimester Abortions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613821
• Other study ID #: OHSU RES 2173
• Status: Completed
• Phase: N/A
• First received: January 31, 2008
• Last updated: July 28, 2017
• Start date: September 2007
• Est. completion date: May 2008

Study information

• Verified date: July 2017
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lidocaine
5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.
• Lidocaine
Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon
United States	Planned Parenthood of the Columbia Willamette	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Effects of an Intrauterine Lidocaine Infusion to Standard Paracervical Block on Decreasing Patient Pain Measured by Visual Analog Scale in First Trimester Abortions.	Subjects perception of pain is measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0 (no pain) to 100 (worst pain imaginable).	Immediately (time zero) at uterine aspiration