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Status unknownNCT02767076Updated May 10, 2016

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

An interventional study of conventional paramedian spinal anesthesia and ultrasound guided paramedian spinal anesthesia in Paramedian Spinal Anaesthesia and Real Time Ultrasound Guiding, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-10.

Sponsored by Cairo University · Not applicable and Interventional

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Paramedian Spinal Anaesthesia
  • Real Time Ultrasound Guiding

Keywords

  • paramedian spinal anesthesia
  • real time
  • ultrasound
  • knee surgeries
  • conventional
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Active comparator
    Conventional

    conventional paramedian spinal anesthesia

    Procedure: conventional paramedian spinal anesthesia

  • Experimental
    Ultrasound

    ultrasound guided paramedian spinal anesthesia

    Device: ultrasound guided paramedian spinal anesthesia

Interventions

  • Procedureconventional paramedian spinal anesthesia

    land mark guided paramedian spinal anesthesia

  • Deviceultrasound guided paramedian spinal anesthesia

    real time ultrasound guided paramedian spinal anesthesia

06

What researchers measure

Primary outcomes

  1. Number of puncture attempts

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

Secondary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Faculty of medicine
    Cairo, 12511, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02767076
Lead sponsor
Cairo University
Responsible party
Sohib Mohamed Galal Abdelfatah (anesthesia specialist, Cairo University) — Principal investigator
First posted
May 10, 2016
Start date
Apr 2016
Primary completion
Apr 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
May 10, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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