Paramedian Spinal AnaesthesiaNCT02767076
Paramedian Spinal Anaesthesia : Comparison Between Land-mark Guided Technique and Real-time Ultrasound Guided Technique.
A study testing conventional paramedian spinal anesthesia and ultrasound guided paramedian spinal anesthesia in people with Paramedian Spinal Anaesthesia and Real Time Ultrasound Guiding, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Paramedian Spinal Anaesthesia, Real Time Ultrasound Guiding
- What is being tested?
- conventional paramedian spinal anesthesia and ultrasound guided paramedian spinal anesthesia
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine
Cairo, Cairo Governorate, 12511
sheeren M Amin, professor, 00201227394557, alyandfarah@gmail.com
About this study
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.
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.
- Being tested
- conventional paramedian spinal anesthesia, ultrasound guided paramedian spinal anesthesia
- Keywords
- paramedian spinal anesthesia, real time, ultrasound, knee surgeries, conventional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional paramedian spinal anesthesiaProcedure or surgery
land mark guided paramedian spinal anesthesia
ultrasound guided paramedian spinal anesthesiaDevice
real time ultrasound guided paramedian spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | conventional paramedian spinal anesthesia Receives: Procedure: conventional paramedian spinal anesthesia |
| Ultrasound | Experimental | ultrasound guided paramedian spinal anesthesia Receives: Device: ultrasound guided paramedian spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of puncture attempts
Measured: during the time taken for introducing the regional anesthetic technique in the intraoperative period
Secondary outcomes (7)
Landmark palpation easiness score
Measured: 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.
Measured: during the time taken for introducing the regional anesthetic technique in the intraoperative period
Duration of the anaesthetic procedure
Measured: during the time taken for introducing the regional anesthetic technique in the intraoperative period
The incidence of paraesthesia and backache
Measured: 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.
Measured: during the time taken for introducing the regional anesthetic technique in the intraoperative period
Patient's satisfaction score regarding the anaesthetic technique
Measured: within 2 hours in the postoperative period
Post dural puncture headache (incidence-onset-duration-severity)
Measured: within 3 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paramedian Spinal AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sohib Mohamed Galal Abdelfatah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767076
- Sponsor's protocol ID
- N-15-2016
- Status last verified
- May 2016
- First submitted
- 22 Apr 2016
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02767076
- Acronym / sponsor ID
- N-15-2016
- Keywords
- paramedian spinal anesthesia, real time, ultrasound, knee surgeries, conventional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 10 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Procedure: conventional paramedian spinal anesthesiaconventional paramedian spinal anesthesia |
| Ultrasound | Experimental | Device: ultrasound guided paramedian spinal anesthesiaultrasound guided paramedian spinal anesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- ASA physical status I-II patients
- Patient's consented approval
- Males or Females
- Aged 18-60 years old
- Body mass index less than 30
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional paramedian spinal anesthesialand mark guided paramedian spinal anesthesia | Procedure or surgery | Conventional |
| ultrasound guided paramedian spinal anesthesiareal time ultrasound guided paramedian spinal anesthesia | Device | Ultrasound |
Primary outcome
Number of puncture attempts
Time frame: during the time taken for introducing the regional anesthetic technique in the intraoperative period
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional paramedian spinal anesthesia and ultrasound guided paramedian spinal anesthesia in people with Paramedian Spinal Anaesthesia and Real Time Ultrasound Guiding, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of puncture attempts (time frame: during the time taken for introducing the regional anesthetic technique in the intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2016.