"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This study has been withdrawn prior to enrollment.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

September 13, 2005
December 27, 2007
Not Provided
Not Provided
  • Number of attempts
  • Incidence of incorrect epidural placement
  • Pain level 1-10
Same as current
Complete list of historical versions of study NCT00178750 on ClinicalTrials.gov Archive Site
Subjective difficulty in placing epidural
Same as current
Not Provided
Not Provided
 
"Loss of Resistance" Versus CompuFlo® for Epidural Placement
A Randomized Clinical Comparison of the "Loss of Resistance" Technique Versus the CompuFlo® Computerized Syringe Pump for Proper Epidural Placement

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).

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Pain
  • Epidural Analgesia
  • Device: 18G Tuohy epidural needle
  • Device: CompuFlo® computerized syringe pump
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
100
Not Provided
Not Provided

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
Female
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00178750
HSC-MS-04-248
Not Provided
Not Provided
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Oscar Ghelber, M.D. The University of Texas Medical School at Houston
The University of Texas Health Science Center, Houston
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP