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Lidocaine and Pain Management in First Trimester Abortions
This study is currently recruiting participants.
Verified by Oregon Health and Science University, September 2007
Sponsored by: Oregon Health and Science University
Information provided by: Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00613821
  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

Drug Information available for: Lidocaine
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Official Title: A Comparison of Intrauterine Lidocaine Infusion and Paracervical Block for Pain Management in First Trimester Abortions

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: After enrollment is complete ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: September 2007
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Lidocaine
5mL intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.
2: Active Comparator Drug: Lidocaine
Standard paracervical block (8mL 1% lidocaine at 4 and 8 o'clock at the cervico-vaginal reflection) will be placed.

Detailed Description:

We 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 cervico-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 5mL 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 (8mL 1% lidocaine at 4 and 8 o'clock at the cervico-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/IM 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613821

Contacts
Contact: Dafna Lohr, MD 503 494-8311

Locations
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Alison Edelman, M.D., M.P.H.            
Sub-Investigator: Dafna Lohr, M.D.            
Sub-Investigator: Jeffrey Jensen, M.D., M.P.H.            
Sub-Investigator: Mark Nichols, M.D.            
Sub-Investigator: Michelle Isley, M.D.            
Sub-Investigator: Paula Bednarek, M.D., M.P.H.            
Planned Parenthood of the Columbia Willamette Recruiting
Portland, Oregon, United States, 96822
Principal Investigator: Alison Edelman, M.D., M.P.H.            
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

Women's Health Research Unit website  This link exits the ClinicalTrials.gov site

Responsible Party: OHSU ( Alison Edelman, MD, MPH )
Study ID Numbers: OHSU RES 2173
Study First Received: January 31, 2008
Last Updated: February 12, 2008
ClinicalTrials.gov Identifier: NCT00613821  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Lidocaine
Pain

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 13, 2009