Paracervical Versus Intracervical Lidocaine - Full Text View

Sponsored by:	University of California, San Diego
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00816751

Purpose

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.

Condition	Intervention
Abortion, Induced Pain	Procedure: Paracervical block Procedure: Intracervical Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Paracervical Versus Intracervical Lidocaine for Suction Curettage: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

Drug Information available for: Vasopressins Argipressin Lidocaine Sodium bicarbonate

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	132
Study Start Date:	December 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	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.
2: Experimental	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.

Arms

Assigned Interventions

1: Active Comparator

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.

2: Experimental

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816751

Locations

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

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator:

Jennifer L Mankowski, MD

UCSD

More Information

No publications provided

Responsible Party:	UCSD Department of Reproductive Medicine ( Jennifer L. Mankowski, MD )
Study ID Numbers:	ONG-08-1781
Study First Received:	December 31, 2008
Last Updated:	January 2, 2009
ClinicalTrials.gov Identifier:	NCT00816751 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:

Local anesthesia
Paracervical
Intracervical

Abortion
Pain
Local anesthesia for elective first trimester abortion

Study placed in the following topic categories:

Arginine Vasopressin
Vasoconstrictor Agents
Vasopressins
Lidocaine
Central Nervous System Depressants
Anesthetics

Pain
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Cardiovascular Agents
Anesthetics, Local
Hemostatics

Additional relevant MeSH terms:

Coagulants
Hematologic Agents
Physiological Effects of Drugs
Lidocaine
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents
Hemostatics
Pharmacologic Actions
Anesthetics, Local

Sensory System Agents
Natriuretic Agents
Therapeutic Uses
Vasopressins
Vasoconstrictor Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Antidiuretic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 02, 2009