Identification of Epidural Space Description of New Technique

NCT02764502 | Completed DMC

• 1 other identifier: 010007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 ).

Conditions

Anesthesia

Keywords

Epidural Identification pressure gauge

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• The physician satisfaction with the technique (Definitely not, Not completely, Yes)

  12hours after the end of the technique

Study Arms (1)

Pressure Gauge Manometer

EXPERIMENTAL

Tuohy needle is introduced into intervertebral space at the level of L3-L4 up to the interspinous ligaments . 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 ).

Device: Pressure Gauge Manometer

Interventions

Pressure Gauge Manometer DEVICE

Identification of epidural space

Pressure Gauge Manometer

Eligibility Criteria

• Age: 28 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Osama Ali Ibraheim: lead

Study Sites (1)

Assiut University ,Faculty Of Medicine ,Anesthesia Department, Egypt

Asyut, Asyut Governorate, 71515, Egypt

Location

Study Officials

• Osama A Ibraheim, MD

  Assiut University College of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Of Anesthesia

Study Record Dates

• First Submitted: April 10, 2016
• First Posted: May 6, 2016
• Study Start: March 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 6, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)