Cesarean SectionNCT01440400
Ultrasound Guided Spinal Anesthesia in Non Obese Obstetric Patients
A study testing Ultrasound guided spinal anesthesia in people with Cesarean Section, run by Corniche Hospital at 1 site in United Arab Emirates.
Trial summary
The classical method for spinal anesthesia relies on the use of bony landmarks to identify the level and point of entry of the spinal needle. Over the years, in experienced hands, this method consistently proved to be successful and safe. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Ultrasound guided spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Oct 2011to Oct 2012
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All mothers with body mass index (BMI) equal to or less than 35 who has normal singleton pregnancy
- At 37 weeks gestation or more
- Admitted to Corniche Hospital for elective caesarean section under spinal anaesthesia
Who cannot join
- Patients with BMI >35
- Patieints with difficult anatomical landmarks
- Patients with neurological disease or coagulation defects
- Patients receiving anticoagulants
- Patients refusing spinal anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Ultrasound to Guide Spinal Anesthesia in Obstetrics. Is There an Advantage Over Landmark Technique in Non-obese Patients?
The classical method for spinal anesthesia relies on the use of bony landmarks to identify the level and point of entry of the spinal needle. Over the years, in experienced hands, this method consistently proved to be successful and safe.
The introduction of ultrasound to guide neuraxial anaesthesia into clinical practice was relatively slow compared to peripheral nerve blocks or central venous catheterization. This could be due to the technical difficulties posed by the bony structures surrounding the spinal cord and its dura that blocks the path of the ultrasound beam. Many anesthetists are reluctant to change their conventional landmark technique, particularly with most studies showing no change in the success rate between ultrasound guided and the landmark techniques.
Read more
Several studies however showed that the ultrasound guided approach reduces the number of attempts to achieve a successful block and reduces the procedure time particularly in obese patients and those with technical difficulties.
In this study the investigators are trying to answer the following question : Is there any advantage in using ultrasound to guide spinal anaesthesia in non obese obstetric patients with easily palpable bony landmarks?
Read the detailed description
Patients will be randomized using a web based randomization program into two groups: Ultrasound guided spinal anesthesia (US) \& conventional spinal anesthesia (C). In both groups, the level of the third or fourth lumbar inter-space (L3/4 or L4/5) will be identified using either ultrasound (transverse and longitudinal approach) or palpation method using anatomical landmarks.
All ultrasound examinations and spinal anesthesia will be performed by 3 anesthetists with experience in ultrasound guided neuraxial block (between 100 and 200 cases). The ultrasound examination will be done using Logiq e TM ultrasound machine (GE Solingen Germany) with 4C RS 2 - 5.5MHz Broadband multi-frequency probe.
The predetermined point of entry for the introducer needle will be marked on the patient's back. The spinal anaesthesia will be administered with the patient in the sitting position, using a 26 gauge pencil point needle (PortexTM) with 15 mg of heavy Bupivacaine and 20 micrograms of Fentanyl. An independent observer, who is blinded to the method used to identify the point of entry of the introducer needle, will be collecting the data.The spinal anesthesia will be labeled as successful if a bilateral block to the sixth thoracic dermatome (T6) , judged by loss of cold and touch discrimination, is established 5 minutes after the spinal injection.
- Conditions
- Cesarean Section
- Being tested
- Ultrasound guided spinal anesthesia
- Keywords
- Ultrasound, Spinal anesthesia, Cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided spinal anesthesiaProcedure or surgery
Using the ultrasound to identify the spinal puncture level, mid-line and the depth of the dura.
| Study group | Role | What they receive |
|---|---|---|
| Conventional spinal anesthesia | No intervention | Not described |
| Ultrasound guided spinal anesthesia | Experimental | Not described Receives: Procedure: Ultrasound guided spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of skin punctures
Number of times the skin is punctured by the introducer needle.
Measured: 30 minutes
The number of spinal needle passes
The number of times the spinal needle tip is advanced beyond the tip of the introducer needle.
Measured: 30 minutes
The time of the procedure
From skin puncture by the introducer to viewing cerebro-spinal fluid back-flow at the hub of the spinal needle.
Measured: 30 minutes
Secondary outcomes (2)
The patient satisfaction with spinal anesthesia
scale 0-10, 0=not satisfied, 10=completely satisfied
Measured: 24 hours
Backache after spinal needle placement, assessed within 24 hours postoperatively
verbal rating scale(VRS), 0-10, 0=no pain, 10=maximum pain.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corniche Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tarek Ansari, Corniche Hospital
- Investigators
- Tarek Ansari, FFARCSI, Principal investigator, Corniche HospitalMounir Fayez, MD, Principal investigator, Corniche HospitalAmr Maher, MD, Principal investigator, Corniche HospitalAhmed El Gamassy, MD, Principal investigator, Corniche Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440400
- Sponsor's protocol ID
- ch3151105
- Status last verified
- Mar 2013
- First submitted
- 22 Sep 2011
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Ultrasound to Guide Spinal Anesthesia in Obstetrics. Is There an Advantage Over Landmark Technique in Non-obese Patients?
- ClinicalTrials.gov ID
- NCT01440400
- Acronym / sponsor ID
- ch3151105
- Conditions
- Cesarean Section
- Keywords
- Ultrasound, Spinal anesthesia, Cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Corniche HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 26 Sep 2011 (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.
The classical method for spinal anesthesia relies on the use of bony landmarks to identify the level and point of entry of the spinal needle. Over the years, in experienced hands, this method consistently proved to be successful and safe.
The introduction of ultrasound to guide neuraxial anaesthesia into clinical practice was relatively slow compared to peripheral nerve blocks or central venous catheterization. This could be due to the technical difficulties posed by the bony structures surrounding the spinal cord and its dura that blocks the path of the ultrasound beam. Many anesthetists are reluctant to change their conventional landmark technique, particularly with most studies showing no change in the success rate between ultrasound guided and the landmark techniques.
Several studies however showed that the ultrasound guided approach reduces the number of attempts to achieve a successful block and reduces the procedure time particularly in obese patients and those with technical difficulties.
In this study the investigators are trying to answer the following question : Is there any advantage in using ultrasound to guide spinal anaesthesia in non obese obstetric patients with easily palpable bony landmarks?
Detailed description
Patients will be randomized using a web based randomization program into two groups: Ultrasound guided spinal anesthesia (US) \& conventional spinal anesthesia (C). In both groups, the level of the third or fourth lumbar inter-space (L3/4 or L4/5) will be identified using either ultrasound (transverse and longitudinal approach) or palpation method using anatomical landmarks.
All ultrasound examinations and spinal anesthesia will be performed by 3 anesthetists with experience in ultrasound guided neuraxial block (between 100 and 200 cases). The ultrasound examination will be done using Logiq e TM ultrasound machine (GE Solingen Germany) with 4C RS 2 - 5.5MHz Broadband multi-frequency probe.
The predetermined point of entry for the introducer needle will be marked on the patient's back. The spinal anaesthesia will be administered with the patient in the sitting position, using a 26 gauge pencil point needle (PortexTM) with 15 mg of heavy Bupivacaine and 20 micrograms of Fentanyl. An independent observer, who is blinded to the method used to identify the point of entry of the introducer needle, will be collecting the data.The spinal anesthesia will be labeled as successful if a bilateral block to the sixth thoracic dermatome (T6) , judged by loss of cold and touch discrimination, is established 5 minutes after the spinal injection.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional spinal anesthesia | No intervention | – |
| Ultrasound guided spinal anesthesia | Experimental | Procedure: Ultrasound guided spinal anesthesia |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All mothers with body mass index (BMI) equal to or less than 35 who has normal singleton pregnancy
- At 37 weeks gestation or more
- Admitted to Corniche Hospital for elective caesarean section under spinal anaesthesia
Key exclusion criteria (5 listed)
- Patients with BMI >35
- Patieints with difficult anatomical landmarks
- Patients with neurological disease or coagulation defects
- Patients receiving anticoagulants
- Patients refusing spinal anaesthesia
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 |
|---|---|---|
| Ultrasound guided spinal anesthesiaUsing the ultrasound to identify the spinal puncture level, mid-line and the depth of the dura. | Procedure or surgery | Ultrasound guided spinal anesthesia |
Primary outcome
The number of skin punctures
Time frame: 30 minutes
Number of times the skin is punctured by the introducer needle.
The number of spinal needle passes
Time frame: 30 minutes
The number of times the spinal needle tip is advanced beyond the tip of the introducer needle.
The time of the procedure
Time frame: 30 minutes
From skin puncture by the introducer to viewing cerebro-spinal fluid back-flow at the hub of the spinal needle.
2 secondary outcomes
The patient satisfaction with spinal anesthesia
Time frame: 24 hours
Backache after spinal needle placement, assessed within 24 hours postoperatively
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
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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.
Tarek Ansari, FFARCSI principal investigator
Corniche Hospital
Mounir Fayez, MD principal investigator
Corniche Hospital
Amr Maher, MD principal investigator
Corniche Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided spinal anesthesia in people with Cesarean Section, run by Corniche Hospital at 1 site in United Arab Emirates.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 12 Mar 2013. 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 United Arab Emirates. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of skin punctures (time frame: 30 minutes). The study lists 3 primary outcomes in all. 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 12 Mar 2013.