Ultrasound Versus Palpation for Epidural Catheterization

Not Applicable

Completed

• Conditions: Spinal Ultrasound; Epidural Anesthesia
• Interventions: Procedure: Double-space combined spinal-epidural anesthesia; Radiation: Sham ultrasound procedure; Radiation: Preprocedure spinal ultrasound

• Registration Number: NCT02410226
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study First Submitted: 2015-03-30
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-07
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palpation	Double-space combined spinal-epidural anesthesia	Double-space combined spinal-epidural anesthesia, Sham ultrasound procedure
Palpation	Sham ultrasound procedure	Double-space combined spinal-epidural anesthesia, Sham ultrasound procedure
Ultrasound	Double-space combined spinal-epidural anesthesia	Double-space combined spinal-epidural anesthesia, Preprocedure spinal ultrasound
Ultrasound	Preprocedure spinal ultrasound	Double-space combined spinal-epidural anesthesia, Preprocedure spinal ultrasound

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Patient satisfaction (5-point scale)	24 hours after delivery	5-point scale
Rate of Inadvertent dural puncture	24 hours after delivery
Rate of Back pain	24 hours after delivery
Number of needle passes required for successful epidural catheterization	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.
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 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.
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 Inadvertent vascular puncture	24 hours after delivery

Trial Locations

Locations (1)

Department of Anesthesia, Mansoura University Hospitals; 🇪🇬 Mansoura, Dakahlia, Egypt