Local Anesthesia and Pain Perception During an Amniocentesis

NCT ID: NCT00583011

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-05-31

Brief Summary

This study is been designed to answer the question of whether local anesthesia (1% lidocaine) decreases the perception of pain associated with amniocentesis in a randomized double blind placebo controlled manner. Our objective is to determine the effect of local anesthesia on the maternal pain perception from an amniocentesis.

Detailed Description

Women meeting criteria for project and agreeing to treatment will be randomized into either the 1% Lidocaine or placebo(normal saline) group. The initial injection of either 1% lidocaine or placebo (normal saline) will be administered 2 minutes prior to the amniocentesis procedure. 2cc of 1% lidocaine or placebo (normal saline) will be initially administered as an intradermal "wheal", followed by a deeper infiltration of the 1% lidocaine or placebo (normal saline) to the depth of the peritoneum. All procedures will be performed by either the Maternal-Fetal medicine (MFM) or the reproductive geneticist utilizing continuous ultrasound guidance under sterile conditions. Each woman will be asked to rate their pain perception immediately after the procedure on two pain scales.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Local Anesthesia

Local anesthesia group. 2cc of 1% lidocaine with epinephrine administered 2 minutes before amniocentesis, using a 21 gauge needle initially as an intradermal wheal followed by a deeper infiltration of 2cc of 1% lidocaine to the depth of the peritoneum.

Group Type: EXPERIMENTAL

Local Anesthesia

Intervention Type: DRUG

Local anesthesia: 2 cc of 1% Lidocaine

Placebo-Normal saline

Placebo normal saline group. 2cc of normal saline epinephrine administered 2 minutes before amniocentesis, using a 21 gauge needle initially as an intradermal wheal followed by a deeper infiltration of 2cc of normal saline to the depth of the peritoneum.

Group Type: PLACEBO_COMPARATOR

Placebo Group

Intervention Type: DRUG

Placebo Group: 2cc Normal Saline

Interventions

Local Anesthesia

Local anesthesia: 2 cc of 1% Lidocaine

Intervention Type: DRUG

Placebo Group

Placebo Group: 2cc Normal Saline

Intervention Type: DRUG

Other Intervention Names

Amniocentesis; Amniocentesis

Eligibility Criteria

Inclusion Criteria

• Singleton pregnancies
• Signed consent to participate in the trial
• Women between the ages of 18 and 45 years
• Gestational ages 15 - 24 weeks

Exclusion Criteria

• Multiple gestation
• Refusal to participate in the trial
• Known hypersensitivity to lidocaine
• Amniocentesis during this pregnancy
• Amnioinfusion/amnioreduction where the procedure is likely to be prolonged

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Elimian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

AmniocentesisPain

Identifier Type: -

Identifier Source: org_study_id