Paracervical Versus Intracervical Lidocaine

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00816751
First received: December 31, 2008
Last updated: January 2, 2009
Last verified: January 2009

December 31, 2008
January 2, 2009
December 2007
February 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00816751 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Paracervical Versus Intracervical Lidocaine
Paracervical Versus Intracervical Lidocaine for Suction Curettage: A Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Abortion, Induced
  • Pain
  • 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.
  • 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.
  • Active Comparator: 1
    Interventions:
    • Procedure: Paracervical block
    • Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate
  • Experimental: 2
    Interventions:
    • Procedure: Intracervical
    • Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00816751
ONG-08-1781
Yes
Jennifer L. Mankowski, MD, UCSD Department of Reproductive Medicine
University of California, San Diego
Not Provided
Principal Investigator: Jennifer L Mankowski, MD UCSD
University of California, San Diego
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP