Lidocaine and Pain Management in First Trimester Abortions

NCT ID: NCT00613821

Last Updated: 2017-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-05-31

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).

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Lidocaine infusion

5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.

Paracervical block only

Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.

Interventions

Lidocaine

5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.

Intervention Type: DRUG

Lidocaine

Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Alison Edelman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alison Edelman, M.D., M.P.H

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Planned Parenthood of the Columbia Willamette

Portland, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16449111 (View on PubMed)

Other Identifiers

OHSU RES 2173

Identifier Type: -

Identifier Source: org_study_id