Epidural AnesthesiaNCT02410226
Ultrasound Versus Palpation for Epidural Catheterization
A study testing Double-space combined spinal-epidural anesthesia and Preprocedure spinal ultrasound in people with Epidural Anesthesia and Spinal Ultrasound, run by Mansoura University at 1 site in Egypt.
Trial summary
The study will assess the benefit of using spinal ultrasound before epidural catheter insertion compared to the conventional palpation technique in women undergoing cesarean section. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Epidural Anesthesia, Spinal Ultrasound
- What is being tested?
- Double-space combined spinal-epidural anesthesia and Preprocedure spinal ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2015to Sep 2015
- 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists class I or II.
- Full term parturients scheduled for elective cesarean delivery under combined spinal-epidural anesthesia.
Who cannot join
- Body mass index ≥ 35 kg/m2.
- Patients having any contraindication to neuraxial anesthesia (Refusal of the procedure, Coagulopathy, Uncorrected hypovolemia, Increased intracranial pressure, Local skin infection).
- Marked spinal deformity or previous spinal surgery.
- Unpalpable anatomical landmarks.
- Emergent situations.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Comparison Between Ultrasound-assisted and Conventional Palpation Techniques for Epidural Catheterization Before Cesarean Section
The study will assess the benefit of using spinal ultrasound before epidural catheter insertion compared to the conventional palpation technique in women undergoing cesarean section.
Read the detailed description
The study will compare the ultrasound-assisted and the conventional palpation techniques for epidural catheterization as a component of combined spinal-epidural anesthesia for cesarean section.
Participants will be randomly assigned into 2 equal groups. In the ultrasound group: Preprocedure lumbar spinal ultrasound will be performed before epidural catheterization. In the palpation group: Conventional technique of landmark palpation will be used.
- Conditions
- Epidural Anesthesia, Spinal Ultrasound
- Being tested
- Double-space combined spinal-epidural anesthesia, Preprocedure spinal ultrasound, Sham ultrasound procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-space combined spinal-epidural anesthesiaProcedure or surgery
Epidural space identification in Lumbar 2-3 or 3-4 space using loss of resistance to air technique with 18-gauge Tuohy needle, then threading a 20-gauge multi-orifice epidural catheter 4-5 cm into the epidural space. Spinal anesthesia administration in an appropriate lower intervertebral space with intrathecal bupivacaine 12.5 mg and fentanyl 10 mcg through a 27-gauge spinal needle.
Preprocedure spinal ultrasoundRadiation
Lumbar spinal ultrasound using the 2-5 MHz curved probe, performed in both the longitudinal and transverse planes for identification of the appropriate intervertebral spce, estimation of the depth to the epidural space, and noting the proper angle for subsequent needle insertion. Then skin markings relying on the ultrasound procedure are made identifying 2 intervertebral spaces.
Sham ultrasound procedureRadiation
Applying the ultrasound probe on the patient's back while the ultrasound machine is on the freeze position.Then skin markings relying on landmark palpation are made identifying 2 intervertebral spaces.
| Study group | Role | What they receive |
|---|---|---|
| Palpation | Active comparator | Double-space combined spinal-epidural anesthesia, Sham ultrasound procedure Receives: Procedure: Double-space combined spinal-epidural anesthesia; Radiation: Sham ultrasound procedure |
| Ultrasound | Experimental | Double-space combined spinal-epidural anesthesia, Preprocedure spinal ultrasound Receives: Procedure: Double-space combined spinal-epidural anesthesia; Radiation: Preprocedure spinal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful epidural catheterization at the first needle pass
Needle pass includes any forward advancement of the Tuohy needle.
Measured: 24 hours after delivery
Secondary outcomes (10)
Rate of successful epidural catheterization at the first skin puncture
Skin puncture includes any separate skin puncture by the Tuohy needle.
Measured: 24 hours after delivery
Number of needle passes required for successful epidural catheterization
Measured: 24 hours after delivery
Number of skin punctures required for successful epidural catheterization
Measured: 24 hours after delivery
Time of the epidural catheterization procedure
From the initial Tuohy needle insertion through the skin to the completion of the threading of the epidural catheter.
Measured: 24 hours after delivery
Patient satisfaction (5-point scale)
5-point scale
Measured: 24 hours after delivery
Rate of Inadvertent dural puncture
Measured: 24 hours after delivery
Rate of Inadvertent vascular puncture
Measured: 24 hours after delivery
Rate of Failed block
Complete failure of epidural catheter after 2 doses of epidural injection of 10 ml bupivacaine 0.25% and fentanyl 20 mcg administered 20 min apart.
Measured: At the first request of analgesia
Unilateral / Patchy block (Assessed by pinprick)
Assessed by pinprick after 20 min of epidural injection of 10 ml bupivacaine 0.25% and fentanyl 20 mcg
Measured: At the first request of analgesia
Rate of Back pain
Measured: 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural AnesthesiaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mohamed Tawfik, Mansoura University
- Investigators
- Mohamed M Tawfik, M.Sc., Principal investigator, Department of Anesthesia and Surgical Intensive Care, Mansoura University Hospitals.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410226
- Sponsor's protocol ID
- R115
- Status last verified
- Sep 2015
- First submitted
- 30 Mar 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound-assisted and Conventional Palpation Techniques for Epidural Catheterization Before Cesarean Section
- ClinicalTrials.gov ID
- NCT02410226
- Acronym / sponsor ID
- R115
- Conditions
- Epidural Anesthesia, Spinal Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Apr 2015 (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 study will assess the benefit of using spinal ultrasound before epidural catheter insertion compared to the conventional palpation technique in women undergoing cesarean section.
Detailed description
The study will compare the ultrasound-assisted and the conventional palpation techniques for epidural catheterization as a component of combined spinal-epidural anesthesia for cesarean section.
Participants will be randomly assigned into 2 equal groups. In the ultrasound group: Preprocedure lumbar spinal ultrasound will be performed before epidural catheterization. In the palpation group: Conventional technique of landmark palpation will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palpation | Active comparator | Procedure: Double-space combined spinal-epidural anesthesia, Radiation: Sham ultrasound procedureDouble-space combined spinal-epidural anesthesia, Sham ultrasound procedure |
| Ultrasound | Experimental | Procedure: Double-space combined spinal-epidural anesthesia, Radiation: Preprocedure spinal ultrasoundDouble-space combined spinal-epidural anesthesia, Preprocedure spinal ultrasound |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists class I or II.
- Full term parturients scheduled for elective cesarean delivery under combined spinal-epidural anesthesia.
Key exclusion criteria (5 listed)
- Body mass index ≥ 35 kg/m2.
- Patients having any contraindication to neuraxial anesthesia (Refusal of the procedure, Coagulopathy, Uncorrected hypovolemia, Increased intracranial pressure, Local skin infection).
- Marked spinal deformity or previous spinal surgery.
- Unpalpable anatomical landmarks.
- Emergent situations.
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 |
|---|---|---|
| Double-space combined spinal-epidural anesthesiaEpidural space identification in Lumbar 2-3 or 3-4 space using loss of resistance to air technique with 18-gauge Tuohy needle, then threading a 20-gauge multi-orifice epidural catheter 4-5 cm into the epidural space. Spinal anesthesia administration in an appropriate lower intervertebral space with intrathecal bupivacaine 12.5 mg and fentanyl 10 mcg through a 27-gauge spinal needle. | Procedure or surgery | Palpation, Ultrasound |
| Preprocedure spinal ultrasoundLumbar spinal ultrasound using the 2-5 MHz curved probe, performed in both the longitudinal and transverse planes for identification of the appropriate intervertebral spce, estimation of the depth to the epidural space, and noting the proper angle for subsequent needle insertion. Then skin markings relying on the ultrasound procedure are made identifying 2 intervertebral spaces. | Radiation | Ultrasound |
| Sham ultrasound procedureApplying the ultrasound probe on the patient's back while the ultrasound machine is on the freeze position.Then skin markings relying on landmark palpation are made identifying 2 intervertebral spaces. | Radiation | Palpation |
Primary outcome
Rate of successful epidural catheterization at the first needle pass
Time frame: 24 hours after delivery
Needle pass includes any forward advancement of the Tuohy needle.
10 secondary outcomes
Rate of successful epidural catheterization at the first skin puncture
Time frame: 24 hours after delivery
Number of needle passes required for successful epidural catheterization
Time frame: 24 hours after delivery
Number of skin punctures required for successful epidural catheterization
Time frame: 24 hours after delivery
Time of the epidural catheterization procedure
Time frame: 24 hours after delivery
Patient satisfaction (5-point scale)
Time frame: 24 hours after delivery
Rate of Inadvertent dural puncture
Time frame: 24 hours after delivery
Rate of Inadvertent vascular puncture
Time frame: 24 hours after delivery
Rate of Failed block
Time frame: At the first request of analgesia
Unilateral / Patchy block (Assessed by pinprick)
Time frame: At the first request of analgesia
Rate of Back pain
Time frame: 24 hours after delivery
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 23 Sep 2015.
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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.
Mohamed M Tawfik, M.Sc. principal investigator
Department of Anesthesia and Surgical Intensive Care, Mansoura University Hospitals.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double-space combined spinal-epidural anesthesia and Preprocedure spinal ultrasound in people with Epidural Anesthesia and Spinal Ultrasound, run by Mansoura 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 2 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 23 Sep 2015. 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?
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?
Rate of successful epidural catheterization at the first needle pass (time frame: 24 hours after delivery). 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 23 Sep 2015.