"Loss of Resistance" Versus CompuFlo® for Epidural Placement

This study has been withdrawn prior to enrollment.
(Study did not start due to investigator time constraints)
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00178750
First received: September 13, 2005
Last updated: December 27, 2007
Last verified: December 2007
  Purpose

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).


Condition Intervention Phase
Pain
Epidural Analgesia
Device: 18G Tuohy epidural needle
Device: CompuFlo® computerized syringe pump
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomized Clinical Comparison of the "Loss of Resistance" Technique Versus the CompuFlo® Computerized Syringe Pump for Proper Epidural Placement

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Number of attempts
  • Incidence of incorrect epidural placement
  • Pain level 1-10

Secondary Outcome Measures:
  • Subjective difficulty in placing epidural

Estimated Enrollment: 100
Detailed Description:

It is possible to utilize epidural anesthesia as the sole anesthetic technique for thoracic, abdominal, and lower extremity surgeries, as a method of postoperative pain management after surgery, and for pain relief during labor and delivery. However, despite the various benefits of epidural anesthesia, this procedure is not utilized to its maximum potential in the operating room. One reason for inadequate utilization of this procedure is the difficulty in properly identifying the epidural space. Current techniques for identifying the epidural space rely on the subjective perception of the operator on loss of resistance to air or saline as the needle passes from the ligamentum flavum into the epidural space. CompuFlo®'s pressure-sensing technology provides an objective measurement for proper placement of the epidural.

Very little advancement has been made in improving training to identify the correct location of the epidural space. Epidural anesthesia has a relatively higher failure rate when performed by residents in training. The skills of trainees differ greatly, and there are no standard teaching methods to teach epidural anesthesia. Statistical analysis conducted by Naik et al. concluded that some residents may need as many as 75 attempts at epidural anesthesia to ensure proficiency.

The CompuFlo® is a computerized syringe pump capable of volume and pressure-controlled infusion. It has a pressure sensor and a mathematical algorithm capable of determining the pressure at the needle tip. Pressures are continuously monitored and displayed, which are reflected by acoustic changes in tone. A dramatic pressure decrease and a high tissue compliance (pressure does not increase despite continuous infusion) signifies entrance into the epidural space. Combining a program with a low upper pressure limit and a high infusion rate mimics the technique used by the loss of resistance with saline proponents (constant pressure on the plunger). It combines the "feel" of inserting an epidural needle with the visualization of the pressure level, as well as a sound indicator to indicate proper placement.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Obstetric patients presenting for Cesarean section
  • American Society of Anesthesiologists Physical Classification ≥ IV
  • Contraindications for epidural anesthesia
  • Allergy to local anesthetics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178750

Locations
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Oscar Ghelber, M.D. The University of Texas Medical School at Houston
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00178750     History of Changes
Other Study ID Numbers: HSC-MS-04-248
Study First Received: September 13, 2005
Last Updated: December 27, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Epidural placement
CompuFlo®

ClinicalTrials.gov processed this record on September 14, 2014