Identification of Epidural Space Description of New Technique

Anesthesia Clinical Trial

Official title:

Identification of Epidural Space Description of New Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764502
• Other study ID #: 010007
• Status: Completed
• Phase: N/A
• First received: April 10, 2016
• Last updated: May 5, 2016
• Start date: March 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

Introduction Several attempts have been made to improve or facilitate epidural space detection beside conventional loss of resistant technique. Recently many sophisticated equipment's and techniques have been described which did not received widespread popularity.

Objectives The Investigator describes and assesses the validity of using Pressure Gauge Manometer to confirm correct detection of lumber epidural space, in an inexpensive way.

Methods Tuohy needle is introduced into intervertebral space at the level of L3-L4 up to the interspinous ligaments ( nearly 2cm mark on the needle).A3-way stopcock is connected to the hub of Tuohy needle with the in-line port of the stopcock attached to an air-filled 10 ml syringe. Using a 75 cm extension tube set and create a 30 mm Hg pressure gradient between manometer and the tip of epidural needle , the needle is advanced slowly using both hands while monitoring the manometer reading and is stopped when the pressure suddenly dropped ( the pressure usually drops by 5-10 mm Hg when the tip of the needle inters the epidural space ).

Description:

• A total of 60 consecutive ASA class 1& II patients of ages between 28-68 years scheduled for elective surgery under lumber epidural anesthesia or under general anesthesia with planned post-operative epidural analgesia were enrolled in this study.

Patients with known coagulation disorder, allergy to local anesthetics, skin lesions at the puncture side, or neuromuscular disease were not included.

Patients are placed in sitting position and American society of anesthesiologists standard monitors attached. After skin preparation, draping, and local anesthetic infiltration, an epidural Tuohy needle is introduced into intervertebral space at the level of L3-L4 up to the interspinous ligaments ( nearly 2cm mark on the needle). Fig 1 A3-way stopcock is connected to the hub of Tuohy needle with the in-line port of the stopcock attached to an air-filled 10 ml syringe. Using a 75 cm extension tube set the side port is connected to the Pressure Gauge Manometer held by the assistant. The stopcock is turned so that the needle is in direct continuity with both syringe and pressure Gage manometer. The syringe is used to create a 30 mm Hg pressure reading on the manometer, the stopcock then is turned into "open" to manometer and Tuohy needle and "close" to syringe.

With this 30 mm Hg pressure gradient between manometer and the tip of epidural needle, the needle is advanced slowly using both hands while monitoring the manometer reading and is stopped when the pressure changes ( the pressure usually drops by 5-10 mm Hg when the tip of the needle inters the epidural space ).

The 3-way is then removed and local anesthetic is injected for single shot epidural block or catheter is introduced in the conventional manner and secured by adhesive tap.

Procedure was performed by anesthetists of different levels of experience (consultant, specialist, resident).

Demographic data and type of surgery is recorded along with time of the technique, number of passes required to enter the epidural space, any false LOR, insertion difficulties, accidental dural puncture, or any other complication occurred.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Years to 68 Years

Eligibility

Inclusion Criteria:

• ASA class 1& II patients of ages between 28-68 years scheduled for elective surgery under lumber epidural anesthesia or under general anesthesia with planned post-operative epidural analgesia were enrolled in this study.

Exclusion Criteria:

• Patients with known coagulation disorder, allergy to local anesthetics, skin lesions at the puncture side, or neuromuscular disease were not included

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Pressure Gauge Manometer
Identification of epidural space

Locations

Country	Name	City	State
Egypt	Assiut University ,Faculty Of Medicine ,Anesthesia Department, Egypt	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Osama Ali Ibraheim

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of the technique.	For epidural catheter placement success of the technique is defined as the installation of sensory block after the end of surgery.	10 minutes after the technique.	Yes
Secondary	The physician satisfaction with the technique (Definitely not, Not completely, Yes)		12hours after the end of the technique	Yes