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Paracervical Versus Intracervical Lidocaine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816751
First Posted: January 5, 2009
Last Update Posted: January 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of California, San Diego
  Purpose
The aim of this study is to estimate the efficacy of intracervical versus paracervical block on pain experienced during first trimester suction curettage without the use of preoperative cervical ripening. Because of the theoretical improved reliability of stromal block, the investigators hypothesize that intracervical block would produce lower pain scores than paracervical block at the time of cervical dilation.

Condition Intervention
Abortion, Induced Pain Procedure: Paracervical block Procedure: Intracervical Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paracervical Versus Intracervical Lidocaine for Suction Curettage: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Pain was assessed using a 10 cm linear visual analog scale (VAS) [ Time Frame: at baseline (prior to sedation), at completion of dilation, and at completion of curettage ]

Secondary Outcome Measures:
  • Details related to the procedure including degree of dilation, size of largest curette used, and any complications were also recorded. [ Time Frame: During and after the procedure ]

Enrollment: 132
Study Start Date: December 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Procedure: Paracervical block
The paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inserting the needle to the hub.
Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate
The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.
Experimental: 2 Procedure: Intracervical
The intracervical block was administered using 20 ml of buffered lidocaine and a 1-1/2 inch, 20 gauge needle in order to overcome the increased resistance to injection caused by the cervical stroma. A small amount was injected at the tenaculum site, and the remainder into the cervical stroma at 12, 3, 6, and 9 o'clock, at a depth of 1-1/2 inch by inserting the needle to the hub.
Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate
The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women presenting for elective first trimester abortion

Exclusion Criteria:

  • Gestation over 12 weeks by ultrasound
  • Weight less than 98 pounds
  • Known allergy to lidocaine
  • Known nonviable pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816751


Locations
United States, California
Planned Parenthood
San Diego, California, United States, 92101
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Jennifer L Mankowski, MD UCSD
  More Information

Responsible Party: Jennifer L. Mankowski, MD, UCSD Department of Reproductive Medicine
ClinicalTrials.gov Identifier: NCT00816751     History of Changes
Other Study ID Numbers: ONG-08-1781
First Submitted: December 31, 2008
First Posted: January 5, 2009
Last Update Posted: January 5, 2009
Last Verified: January 2009

Keywords provided by University of California, San Diego:
Local anesthesia
Paracervical
Intracervical
Abortion
Pain
Local anesthesia for elective first trimester abortion

Additional relevant MeSH terms:
Lidocaine
Vasopressins
Arginine Vasopressin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents