Paramedian Spinal Anaesthesia : Comparison Between Land-mark Guided Technique and Real-time Ultrasound Guided Technique.

NCT ID: NCT02767076

Last Updated: 2016-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-09-30

Brief Summary

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To identify the value of using the ultrasound in applying a commonly used regional anaesthetic procedure (spinal anaesthesia) when compared with the conventional landmark guided approach, regarding the efficiency of the anaesthetic technique, incidence of associated common complications and patient's satisfaction.

Detailed Description

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Conditions

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Paramedian Spinal Anaesthesia Real Time Ultrasound Guiding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional

conventional paramedian spinal anesthesia

Group Type ACTIVE_COMPARATOR

conventional paramedian spinal anesthesia

Intervention Type PROCEDURE

land mark guided paramedian spinal anesthesia

Ultrasound

ultrasound guided paramedian spinal anesthesia

Group Type EXPERIMENTAL

ultrasound guided paramedian spinal anesthesia

Intervention Type DEVICE

real time ultrasound guided paramedian spinal anesthesia

Interventions

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conventional paramedian spinal anesthesia

land mark guided paramedian spinal anesthesia

Intervention Type PROCEDURE

ultrasound guided paramedian spinal anesthesia

real time ultrasound guided paramedian spinal anesthesia

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. ASA physical status I-II patients
2. Patient's consented approval
3. Males or Females
4. Aged 18-60 years old
5. Body mass index less than 30
6. Scheduled for orthopaedic knee surgeries

Exclusion Criteria

1. Age less than 18, and more than 60 years
2. Body mass index more than 30
3. Patient refusal or failure to obtain consent
4. Patient in whom spinal anaesthesia is contraindicated (infection at the site of needle insertion, coagulopathy reflected by values of INR≥ 1.2 or platelets count≤ 75.000, or receiving oral anticoagulants)
5. Known sensitivity to local anaesthetics
6. Pre-existing neurological disorder or neuromuscular disease
7. Clinically obvious or known spinal deformity or previous spinal surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sohib Mohamed Galal Abdelfatah

anesthesia specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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sheeren M Amin, professor

Role: primary

00201227394557

Other Identifiers

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N-15-2016

Identifier Type: -

Identifier Source: org_study_id

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