NCT00178750

Brief Summary

The purpose of this study is to compare how well the CompuFlo® computerized syringe pump works as compared to the traditional method of inserting an epidural (a needle placed in one's back to give pain medicine).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

First QC Date

September 13, 2005

Last Update Submit

November 3, 2020

Conditions

PainEpidural Analgesia

Keywords

Epidural placementCompuFlo®

Outcome Measures

Primary Outcomes (3)

  • Number of attempts

  • Incidence of incorrect epidural placement

  • Pain level 1-10

Secondary Outcomes (1)

  • Subjective difficulty in placing epidural

Interventions

18G Tuohy epidural needleDEVICE
CompuFlo® computerized syringe pumpDEVICE

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any obstetric patient presenting for vaginal delivery desiring epidural anesthesia
  • American Society of Anesthesiologists (ASA) Physical Classification I-III
  • Aged 18-65 years

You may not qualify if:

  • Obstetric patients presenting for Cesarean section
  • American Society of Anesthesiologists Physical Classification ≥ IV
  • Contraindications for epidural anesthesia
  • Allergy to local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Oscar Ghelber, M.D.

    The University of Texas Medical School at Houston

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

US(1)