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.

Study Overview

• Status: Completed
• Conditions: Pain; Abortion, Induced
• Intervention / Treatment: Procedure: Paracervical block; Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate; Procedure: Intracervical

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92101
      • Planned Parenthood

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2	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.; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Gestational Age at Time of Procedure	At the time of the procedure

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: December 31, 2008
• First Submitted That Met QC Criteria: January 2, 2009
• First Posted (Estimate): January 5, 2009

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Pain; Local anesthesia; Abortion; Paracervical; Intracervical; Local anesthesia for elective first trimester abortion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Natriuretic Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Hemostatics; Coagulants; Vasoconstrictor Agents; Antidiuretic Agents; Lidocaine; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: ONG-08-1781