Study to Determine Whether the Instillation of 10ml Normal Saline Improves Epidural Analgesia During Labor

NCT01119079 | Withdrawn Phase 3

• 1 other identifier: 0120090228
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In current obstetric anesthesia practice, epidural analgesia is the most effective technique to control labor pain for those women who request pain-free delivery. Epidural analgesia not only allows us to obtain greater pain relief and increased satisfaction of mothers, but also permits us to convert it to regional anesthesia in case of operative delivery, avoiding general anesthesia. One of the major concerns with epidural anesthesia in labor setting is the inability to produce an intensive analgesia or adequate level to proceed with cesarean section. This study is designed to examine the hypothesis that 10ml epidural normal saline to reduce rate of one-side block, low segmental block, and patch block, and improve quality of labor epidural analgesia/ anesthesia in obstetric population.

Conditions

Parturients

Keywords

labor pain; epidural

Outcome Measures

Primary Outcomes (1)

• improve quality of labor epidural analgesia/ anesthesia in obstetric population.

  Administration of epidural anesthesia + 2 hours

Study Arms (2)

Standard labor epidural protocol

PLACEBO COMPARATOR

Standard labor epidural protocol

Procedure: Administration of epidural anesthesia for labor

10ml Normal Saline prior to lidocaine

EXPERIMENTAL

Other: Normal Saline

Interventions

Normal Saline OTHER

10ml Normal Saline instilled in the epidural space

10ml Normal Saline prior to lidocaine

Administration of epidural anesthesia for labor PROCEDURE

Standard procedure

Standard labor epidural protocol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists class I-II term parturients with singleton vertex presentation in active labor
• Patients who have cervical dilatation between 3 and 7 centimeters

You may not qualify if:

• Patients with contraindications to epidural analgesia,
• severe medical or obstetric complications,
• morbid obesity (body mass index \>40 kg/m2),
• history of drug or alcohol abuse,
• abnormal hepatic (AST/ALT), renal (creatinine levels), or hematological (PTT levels) test results.
• presence of blood on the second insertion into the intervertebral space
• presence of cerebral spinal fluid upon insertion into the intervertebral space
• subjects who deliver (either vaginally or via cesarean section) within 2 hours of the epidural insertion
• subjects less than 36 weeks gestation

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead

Study Sites (1)

University Hospital

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dongchen Li, MD, PhD

  UMDNJ-NJMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 7, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 24, 2015

Record last verified: 2015-04

Locations

US (1)