Local Anesthesia and Pain Perception During an Amniocentesis

NCT00583011 | Completed Results

• 1 other identifier: AmniocentesisPain
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Amniocentesis; Genetic amniocentesis; Fetal lung maturity; Pain control; Pregnancy; High risk pregnancy

Outcome Measures

Primary Outcomes (1)

• Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS)

  Visual Analogue Scale (Perpendicular line is drawn at the point that represents pain on a 0-100mm scale, with lower number meaning less pain and the higher number meaning more pain)

  Immediately following amniocentesis procedure

Secondary Outcomes (1)

• Intensity of Perceived Maternal Pain as Measured by the 101 Point Numerical Rating Scale (NRS-101)

  Immediately following amniocentesis procedure

Study Arms (2)

Local Anesthesia

EXPERIMENTAL

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.

Drug: Local Anesthesia

Placebo-Normal saline

PLACEBO COMPARATOR

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.

Drug: Placebo Group

Interventions

Local Anesthesia DRUG

Local anesthesia: 2 cc of 1% Lidocaine

Also known as: Amniocentesis

Local Anesthesia

Placebo Group DRUG

Placebo Group: 2cc Normal Saline

Also known as: Amniocentesis

Placebo-Normal saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, Local; Amniocentesis

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Paracentesis; Specimen Handling; Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Andrew Elimian, MD
• Organization: University of Oklahoma Health Science Center

aelimian@aol.com

9142317323

Study Officials

• Andrew Elimian, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: October 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 3, 2021
• Results First Posted: February 3, 2021

Record last verified: 2021-01

Locations

US (1)