Ultrasound Versus Palpation for Epidural Catheterization
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Palpation Double-space combined spinal-epidural anesthesia, Sham ultrasound procedure |
Procedure: Double-space combined spinal-epidural anesthesia
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.
Radiation: Sham ultrasound procedure
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.
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| Experimental: Ultrasound Double-space combined spinal-epidural anesthesia, Preprocedure spinal ultrasound |
Procedure: Double-space combined spinal-epidural anesthesia
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.
Radiation: Preprocedure spinal ultrasound
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.
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Outcome Measures
Primary Outcome Measures
- Rate of successful epidural catheterization at the first needle pass [24 hours after delivery]
Needle pass includes any forward advancement of the Tuohy needle.
Secondary Outcome Measures
- Rate of successful epidural catheterization at the first skin puncture [24 hours after delivery]
Skin puncture includes any separate skin puncture by the Tuohy needle.
- Number of needle passes required for successful epidural catheterization [24 hours after delivery]
- Number of skin punctures required for successful epidural catheterization [24 hours after delivery]
- Time of the epidural catheterization procedure [24 hours after delivery]
From the initial Tuohy needle insertion through the skin to the completion of the threading of the epidural catheter.
- Patient satisfaction (5-point scale) [24 hours after delivery]
5-point scale
- Rate of Inadvertent dural puncture [24 hours after delivery]
- Rate of Inadvertent vascular puncture [24 hours after delivery]
- Rate of Failed block [At the first request of analgesia]
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.
- Unilateral / Patchy block (Assessed by pinprick) [At the first request of analgesia]
Assessed by pinprick after 20 min of epidural injection of 10 ml bupivacaine 0.25% and fentanyl 20 mcg
- Rate of Back pain [24 hours after delivery]
Other Outcome Measures
- Level of successful epidural catheterization [24 hours after delivery]
The lumbar intervertebral space L 2-3 or 3-4 used for epidural catheter insertion.
Eligibility Criteria
Criteria
Inclusion Criteria:
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American Society of Anesthesiologists class I or II.
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Full term parturients scheduled for elective cesarean delivery under combined spinal-epidural anesthesia.
Exclusion Criteria:
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Body mass index ≥ 35 kg/m2.
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Patients having any contraindication to neuraxial anesthesia (Refusal of the procedure, Coagulopathy, Uncorrected hypovolemia, Increased intracranial pressure, Local skin infection).
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Marked spinal deformity or previous spinal surgery.
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Unpalpable anatomical landmarks.
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Emergent situations.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anesthesia, Mansoura University Hospitals | Mansoura | Dakahlia | Egypt | 35511 |
Sponsors and Collaborators
- Mansoura University
Investigators
- Principal Investigator: Mohamed M Tawfik, M.Sc., Department of Anesthesia and Surgical Intensive Care, Mansoura University Hospitals.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R115