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.

Cairo University1 site in 1 country110 target enrollmentApril 2016

ConditionsParamedian Spinal Anaesthesia Real Time Ultrasound Guiding

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Paramedian Spinal Anaesthesia
Sponsor: Cairo University
Enrollment: 110
Locations: 1
Primary Endpoint: Number of puncture attempts
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

September 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cairo University

Responsible Party

Principal Investigator

Sohib Mohamed Galal Abdelfatah

anesthesia specialist

Cairo University

Eligibility Criteria

Inclusion Criteria

•ASA physical status I-II patients
•Patient's consented approval
•Males or Females
•Aged 18-60 years old
•Body mass index less than 30
•Scheduled for orthopaedic knee surgeries

Exclusion Criteria

•Age less than 18, and more than 60 years
•Body mass index more than 30
•Patient refusal or failure to obtain consent
•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)
•Known sensitivity to local anaesthetics
•Pre-existing neurological disorder or neuromuscular disease
•Clinically obvious or known spinal deformity or previous spinal surgery

Outcomes

Primary Outcomes

Number of puncture attempts

Time Frame: during the time taken for introducing the regional anesthetic technique in the intraoperative period

Secondary Outcomes

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