"Loss of Resistance" Versus CompuFlo® for Epidural Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00178750
Recruitment Status : Withdrawn (Study did not start due to investigator time constraints)
First Posted : September 15, 2005
Last Update Posted : January 8, 2008
Information provided by:
The University of Texas Health Science Center, Houston

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).

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Randomized Clinical Comparison of the "Loss of Resistance" Technique Versus the CompuFlo® Computerized Syringe Pump for Proper Epidural Placement

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

Secondary Outcome Measures :
  1. Subjective difficulty in placing epidural

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00178750

United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Principal Investigator: Oscar Ghelber, M.D. The University of Texas Medical School at Houston Identifier: NCT00178750     History of Changes
Other Study ID Numbers: HSC-MS-04-248
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 8, 2008
Last Verified: December 2007

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