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NCT Number: NCT00816751

Paracervical Versus Intracervical Lidocaine

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.

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Key information

Conditions

Abortion, Induced Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood

San Diego, California, 92101, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracervical block

Procedure

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

Procedure

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.

Buffered Lidocaine, vasopressin, sodium bicarbonate

Drug

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.

Primary outcomes

  1. Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS)

    Time frame: at completion of procedure

    VAS on a scale of 1 to 10 with 1 being lowest pain and 10 highest amount of pain

Secondary outcomes

  1. Gestational Age at Time of Procedure

    Time frame: At the time of the procedure

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 5, 2009
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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