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Identification of Epidural Space Description of New Technique

5. maj 2016 opdateret af: Osama Ali Ibraheim

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 ).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

• 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Assiut, Egypten, 71515
        • Assiut University ,Faculty Of Medicine ,Anesthesia Department, Egypt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

28 år til 68 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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 ).
Identification of epidural space

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Success of the technique.
Tidsramme: 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.
10 minutes after the technique.

Sekundære resultatmål

Resultatmål
Tidsramme
The physician satisfaction with the technique (Definitely not, Not completely, Yes)
Tidsramme: 12hours after the end of the technique
12hours after the end of the technique

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Osama A Ibraheim, MD, Assiut University College of medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2012

Primær færdiggørelse (Faktiske)

1. april 2014

Studieafslutning (Faktiske)

1. april 2014

Datoer for studieregistrering

Først indsendt

10. april 2016

Først indsendt, der opfyldte QC-kriterier

5. maj 2016

Først opslået (Skøn)

6. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 010007

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

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