"Loss of Resistance" Versus CompuFlo® for Epidural Placement

Pain Clinical Trial

Official title:

A Randomized Clinical Comparison of the "Loss of Resistance" Technique Versus the CompuFlo® Computerized Syringe Pump for Proper Epidural Placement

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00178750
• Other study ID #: HSC-MS-04-248
• Status: Withdrawn
• Phase: Phase 1/Phase 2

Study information

• Verified date: November 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Epidural Analgesia
• Pain

Intervention

Device:
• 18G Tuohy epidural needle

• CompuFlo® computerized syringe pump

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of attempts
Primary	Incidence of incorrect epidural placement
Primary	Pain level 1-10
Secondary	Subjective difficulty in placing epidural