Identification of Epidural Space Description of New Technique

Sponsor
Osama Ali Ibraheim (Other)
Overall Status
Completed
CT.gov ID
NCT02764502
Collaborator
(none)
60
1
1
25
2.4

Study Details

Study Description

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 ).

Condition or Disease Intervention/Treatment Phase
  • Device: Pressure Gauge Manometer
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Identification of Epidural Space Description of New Technique
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pressure Gauge Manometer

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
Identification of epidural space

Outcome Measures

Primary Outcome Measures

  1. Success of the technique. [10 minutes after the technique.]

    For epidural catheter placement success of the technique is defined as the installation of sensory block after the end of surgery.

Secondary Outcome Measures

  1. The physician satisfaction with the technique (Definitely not, Not completely, Yes) [12hours after the end of the technique]

Eligibility Criteria

Criteria

Ages Eligible for Study:
28 Years to 68 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University ,Faculty Of Medicine ,Anesthesia Department, Egypt Assiut Egypt 71515

Sponsors and Collaborators

  • Osama Ali Ibraheim

Investigators

  • Principal Investigator: Osama A Ibraheim, MD, Assiut University College of medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Osama Ali Ibraheim, Professor Of Anesthesia, Assiut University
ClinicalTrials.gov Identifier:
NCT02764502
Other Study ID Numbers:
  • 010007
First Posted:
May 6, 2016
Last Update Posted:
May 6, 2016
Last Verified:
May 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Osama Ali Ibraheim, Professor Of Anesthesia, Assiut University

Study Results

No Results Posted as of May 6, 2016