Clinical trial NCT02767076: Paramedian Spinal Anaesthesia : Comparison Between Land-mark Guided Technique and Real-time Ultrasound Guided Technique.
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paramedian Spinal Anaesthesia
Real Time Ultrasound Guiding
Keywords: paramedian spinal anesthesia
real time
ultrasound
knee surgeries
conventional
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: Number of puncture attempts
timeFrame: during the time taken for introducing the regional anesthetic technique in the intraoperative period
Secondary outcomes:
measure: Landmark palpation easiness score
timeFrame: during the time taken for introducing the regional anesthetic technique in the intraoperative period
measure: The visibility of the ligamentum flavum-dura mater complex by the US.
timeFrame: during the time taken for introducing the regional anesthetic technique in the intraoperative period
measure: Duration of the anaesthetic procedure
timeFrame: during the time taken for introducing the regional anesthetic technique in the intraoperative period
measure: The incidence of paraesthesia and backache
timeFrame: during the time taken for introducing the regional anesthetic technique in the intraoperative period
measure: The incidence of failure of introducing spinal anaesthesia using each of the study techniques.
timeFrame: during the time taken for introducing the regional anesthetic technique in the intraoperative period
measure: Patient's satisfaction score regarding the anaesthetic technique
timeFrame: within 2 hours in the postoperative period
measure: Post dural puncture headache (incidence-onset-duration-severity)
timeFrame: within 3 days after the operation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine
Study officials:
References: