Lidocaine and Pain Management in First Trimester Abortions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00613821
First received: January 31, 2008
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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).


Condition Intervention
Pain
Drug: Lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: A Comparison of Intrauterine Lidocaine Infusion and Paracervical Block for Pain Management in First Trimester Abortions

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • The effects of an intrauterine lidocaine infusion to standard paracervical block on decreasing patient pain in first trimester abortions. [ Time Frame: Immediately (time zero) at uterine aspiration ] [ Designated as safety issue: No ]
    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 (furthest point to the left) to 100 (furthest point to the right).


Enrollment: 80
Study Start Date: September 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine infusion
5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.
Drug: Lidocaine
5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.
Active Comparator: Paracervical block only
Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.
Drug: Lidocaine
Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613821

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Planned Parenthood of the Columbia Willamette
Portland, Oregon, United States, 96822
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Alison Edelman, M.D., M.P.H Oregon Health and Science University
  More Information

Publications:
Responsible Party: Alison Edelman, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00613821     History of Changes
Other Study ID Numbers: OHSU RES 2173
Study First Received: January 31, 2008
Last Updated: October 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
surgical abortion
pain management

Additional relevant MeSH terms:
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 21, 2014