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

May 6, 2016 updated by: Sohib Mohamed Galal Abdelfatah, Cairo University

Paramedian Spinal Anaesthesia for Orthopaedic Knee Surgery: Comparison Between Conventional Blind Land-mark Guided Technique and Real-time Ultrasound Guided Technique: a Randomized Controlled Trial.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12511
        • Recruiting
        • Faculty of medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional
conventional paramedian spinal anesthesia
Procedure: conventional paramedian spinal anesthesia
land mark guided paramedian spinal anesthesia
Experimental: Ultrasound
ultrasound guided paramedian spinal anesthesia
Device: ultrasound guided paramedian spinal anesthesia
real time ultrasound guided paramedian spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of puncture attempts
Time Frame: during the time taken for introducing the regional anesthetic technique in the intraoperative period
during the time taken for introducing the regional anesthetic technique in the intraoperative period

Secondary Outcome Measures

Outcome Measure
Time Frame
Landmark palpation easiness score
Time Frame: during the time taken for introducing the regional anesthetic technique in the intraoperative period
during the time taken for introducing the regional anesthetic technique in the intraoperative period
The visibility of the ligamentum flavum-dura mater complex by the US.
Time Frame: during the time taken for introducing the regional anesthetic technique in the intraoperative period
during the time taken for introducing the regional anesthetic technique in the intraoperative period
Duration of the anaesthetic procedure
Time Frame: during the time taken for introducing the regional anesthetic technique in the intraoperative period
during the time taken for introducing the regional anesthetic technique in the intraoperative period
The incidence of paraesthesia and backache
Time Frame: during the time taken for introducing the regional anesthetic technique in the intraoperative period
during the time taken for introducing the regional anesthetic technique in the intraoperative period
The incidence of failure of introducing spinal anaesthesia using each of the study techniques.
Time Frame: during the time taken for introducing the regional anesthetic technique in the intraoperative period
during the time taken for introducing the regional anesthetic technique in the intraoperative period
Patient's satisfaction score regarding the anaesthetic technique
Time Frame: within 2 hours in the postoperative period
within 2 hours in the postoperative period
Post dural puncture headache (incidence-onset-duration-severity)
Time Frame: within 3 days after the operation
within 3 days after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

April 22, 2016

First Submitted That Met QC Criteria

May 6, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 6, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-15-2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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