Paracervical Versus Intracervical Lidocaine

Pain Clinical Trial

Official title:

Paracervical Versus Intracervical Lidocaine for Suction Curettage: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816751
• Other study ID #: ONG-08-1781
• Status: Completed
• Phase: N/A
• Start date: December 2007
• Est. completion date: February 2008

Study information

• Verified date: July 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Induced
• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Planned Parenthood	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS)	VAS on a scale of 1 to 10 with 1 being lowest pain and 10 highest amount of pain	at completion of procedure
Secondary	Gestational Age at Time of Procedure		At the time of the procedure