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Sponsored by: |
Oregon Health and Science University |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00613821 |
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 |
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Pain |
Drug: Lidocaine |
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 |
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 |
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1: Experimental |
Drug: Lidocaine
5mL intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.
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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.
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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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dafna Lohr, MD | 503 494-8311 |
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. |
Principal Investigator: | Alison Edelman, M.D., M.P.H | Oregon Health and Science University |
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 |
surgical abortion pain management |
Lidocaine Pain |
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 |