"Loss of Resistance" Versus CompuFlo® for Epidural Placement

NCT ID: NCT00178750

Last Updated: 2020-11-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL

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).

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.

Conditions

Pain; Epidural Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

18G Tuohy epidural needle

Intervention Type: DEVICE

CompuFlo® computerized syringe pump

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Principal Investigators

Oscar Ghelber, M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Medical School at Houston

Locations

Memorial Hermann Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-04-248

Identifier Type: -

Identifier Source: org_study_id