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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: April 2017

Interventions

  • Procedure: conventional paramedian spinal anesthesia
    • land mark guided paramedian spinal anesthesia
  • Device: ultrasound guided paramedian spinal anesthesia
    • real time ultrasound guided paramedian spinal anesthesia

Arms, Groups and Cohorts

  • Active Comparator: Conventional
    • conventional paramedian spinal anesthesia
  • Experimental: Ultrasound
    • ultrasound guided paramedian spinal anesthesia

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Landmark palpation easiness score
    • Time Frame: 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
  • Duration of the anaesthetic procedure
    • Time Frame: 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
  • 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
  • Patient’s satisfaction score regarding the anaesthetic technique
    • Time Frame: within 2 hours in the postoperative period
  • Post dural puncture headache (incidence-onset-duration-severity)
    • Time Frame: within 3 days after the operation

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sohib Mohamed Galal Abdelfatah, anesthesia specialist – Cairo University

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