Paracervical Versus Intracervical Lidocaine

Not Applicable

Completed

• Conditions: Abortion, Induced; Pain
• Interventions: Procedure: Intracervical; Procedure: Paracervical block; Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate

• Registration Number: NCT00816751
• Lead Sponsor: University of California, San Diego

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2008-12-31
• Study First Submitted QC: 2009-01-02
• Study First Posted: 2009-01-05
• Results First Submitted: 2019-06-04
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-22
• Last Update Submitted: 2019-07-22
• Results First Posted: 2019-08-13
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Intracervical	-
2	Buffered Lidocaine, vasopressin, sodium bicarbonate	-
1	Paracervical block	-
1	Buffered Lidocaine, vasopressin, sodium bicarbonate	-

Primary Outcome Measures

Name	Time	Method
Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS)	at completion of procedure	VAS on a scale of 1 to 10 with 1 being lowest pain and 10 highest amount of pain

Secondary Outcome Measures

Name	Time	Method
Gestational Age at Time of Procedure	At the time of the procedure

Trial Locations

Locations (1)

Planned Parenthood; 🇺🇸 San Diego, California, United States