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

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ClinicalTrials.gov Identifier: NCT02767076
Recruitment Status : Unknown
Verified May 2016 by Sohib Mohamed Galal Abdelfatah, Cairo University.
Recruitment status was:  Recruiting
First Posted : May 10, 2016
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
Sohib Mohamed Galal Abdelfatah, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Paramedian Spinal Anaesthesia Real Time Ultrasound Guiding Procedure: conventional paramedian spinal anesthesia Device: ultrasound guided paramedian spinal anesthesia Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: 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.
Study Start Date : April 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




Primary Outcome Measures :
  1. Number of puncture attempts [ Time Frame: during the time taken for introducing the regional anesthetic technique in the intraoperative period ]

Secondary Outcome Measures :
  1. Landmark palpation easiness score [ Time Frame: during the time taken for introducing the regional anesthetic technique in the intraoperative period ]
  2. 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 ]
  3. Duration of the anaesthetic procedure [ Time Frame: during the time taken for introducing the regional anesthetic technique in the intraoperative period ]
  4. The incidence of paraesthesia and backache [ Time Frame: during the time taken for introducing the regional anesthetic technique in the intraoperative period ]
  5. 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 ]
  6. Patient's satisfaction score regarding the anaesthetic technique [ Time Frame: within 2 hours in the postoperative period ]
  7. Post dural puncture headache (incidence-onset-duration-severity) [ Time Frame: within 3 days after the operation ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767076


Locations
Egypt
Faculty of medicine Recruiting
Cairo, Egypt, 12511
Contact: sheeren M Amin, professor    00201227394557    alyandfarah@gmail.com   
Sponsors and Collaborators
Cairo University

Responsible Party: Sohib Mohamed Galal Abdelfatah, anesthesia specialist, Cairo University
ClinicalTrials.gov Identifier: NCT02767076     History of Changes
Other Study ID Numbers: N-15-2016
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016

Keywords provided by Sohib Mohamed Galal Abdelfatah, Cairo University:
paramedian spinal anesthesia
real time
ultrasound
knee surgeries
conventional

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs