Ultrasound Versus Palpation for Epidural Catheterization

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.

Study Overview

• Status: Completed
• Conditions: Epidural Anesthesia; Spinal Ultrasound
• Intervention / Treatment: Procedure: Double-space combined spinal-epidural anesthesia; Radiation: Sham ultrasound procedure; Radiation: Preprocedure spinal ultrasound

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Department of Anesthesia, Mansoura University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful epidural catheterization at the first needle pass	Needle pass includes any forward advancement of the Tuohy needle.	24 hours after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful epidural catheterization at the first skin puncture	Skin puncture includes any separate skin puncture by the Tuohy needle.	24 hours after delivery
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	From the initial Tuohy needle insertion through the skin to the completion of the threading of the epidural catheter.	24 hours after delivery
Patient satisfaction (5-point scale)	5-point scale	24 hours after delivery
Rate of Inadvertent dural puncture		24 hours after delivery
Rate of Inadvertent vascular puncture		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.	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	At the first request of analgesia
Rate of Back pain		24 hours after delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of successful epidural catheterization	The lumbar intervertebral space L 2-3 or 3-4 used for epidural catheter insertion.	24 hours after delivery

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Mohamed M Tawfik, M.Sc., Department of Anesthesia and Surgical Intensive Care, Mansoura University Hospitals.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: March 30, 2015
• First Submitted That Met QC Criteria: April 6, 2015
• First Posted (Estimate): April 7, 2015

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: R115