Clinical trial NCT02410226: Ultrasound Versus Palpation for Epidural Catheterization
Official title: Comparison Between Ultrasound-assisted and Conventional Palpation Techniques for Epidural Catheterization Before Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidural Anesthesia
Spinal Ultrasound
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 110
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists class I or II.
* Full term parturients scheduled for elective cesarean delivery under combined spinal-epidural anesthesia.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of successful epidural catheterization at the first needle pass
timeFrame: 24 hours after delivery
Secondary outcomes:
measure: Rate of successful epidural catheterization at the first skin puncture
timeFrame: 24 hours after delivery
measure: Number of needle passes required for successful epidural catheterization
timeFrame: 24 hours after delivery
measure: Number of skin punctures required for successful epidural catheterization
timeFrame: 24 hours after delivery
measure: Time of the epidural catheterization procedure
timeFrame: 24 hours after delivery
measure: Patient satisfaction (5-point scale)
timeFrame: 24 hours after delivery
measure: Rate of Inadvertent dural puncture
timeFrame: 24 hours after delivery
measure: Rate of Inadvertent vascular puncture
timeFrame: 24 hours after delivery
measure: Rate of Failed block
timeFrame: At the first request of analgesia
measure: Unilateral / Patchy block (Assessed by pinprick)
timeFrame: At the first request of analgesia
measure: Rate of Back pain
timeFrame: 24 hours after delivery
Other outcomes:
measure: Level of successful epidural catheterization
timeFrame: 24 hours after delivery
Locations:
city: Mansoura
country: Egypt
facility: Department of Anesthesia, Mansoura University Hospitals
state: Dakahlia
Study officials:
affiliation: Department of Anesthesia and Surgical Intensive Care, Mansoura University Hospitals.
name: Mohamed M Tawfik, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: