Paracervical Versus Intracervical Lidocaine

NCT ID: NCT00816751

Last Updated: 2019-08-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-02-29

Brief Summary

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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

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Conditions

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Abortion, Induced Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Paracervical block

Intervention Type 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.

Buffered Lidocaine, vasopressin, sodium bicarbonate

Intervention Type 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.

2

Group Type EXPERIMENTAL

Intracervical

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Jessica Kingston

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Planned Parenthood

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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ONG-08-1781

Identifier Type: -

Identifier Source: org_study_id

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