Local Anesthesia and Pain Perception During an Amniocentesis

University of Oklahoma (OU)

Status: Completed

Conditions: Pregnancy

Treatments: Drug: Local Anesthesia; Drug: Placebo Group

Study type: Interventional

Funder types: Other

Identifiers

NCT00583011

AmniocentesisPain

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 2 patient groups, including a placebo group

Local Anesthesia

Experimental group

Description:

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.

Treatment:

Drug: Local Anesthesia

Placebo-Normal saline

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Group