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

Not Applicable

• Conditions: Paramedian Spinal Anaesthesia; Real Time Ultrasound Guiding
• Interventions: Device: ultrasound guided paramedian spinal anesthesia; Procedure: conventional paramedian spinal anesthesia

• Registration Number: NCT02767076
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-22
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-06
• Last Update Submitted: 2016-05-06
• Study First Posted: 2016-05-10
• Last Update Posted: 2016-05-10
• Primary Completion: 2017-04
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound	ultrasound guided paramedian spinal anesthesia	ultrasound guided paramedian spinal anesthesia
Conventional	conventional paramedian spinal anesthesia	conventional paramedian spinal anesthesia

Primary Outcome Measures

Name	Time	Method
Number of puncture attempts	during the time taken for introducing the regional anesthetic technique in the intraoperative period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Cairo, Egypt