Ultrasound Versus Palpation for Epidural Catheterization

Epidural Anesthesia Clinical Trial

Official title:

Comparison Between Ultrasound-assisted and Conventional Palpation Techniques for Epidural Catheterization Before Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410226
• Other study ID #: R115
• Status: Completed
• Phase: N/A
• First received: March 30, 2015
• Last updated: September 21, 2015
• Start date: April 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epidural Anesthesia
• Spinal Ultrasound

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Department of Anesthesia, Mansoura University Hospitals	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Level of successful epidural catheterization	The lumbar intervertebral space L 2-3 or 3-4 used for epidural catheter insertion.	24 hours after delivery	No
Primary	Rate of successful epidural catheterization at the first needle pass	Needle pass includes any forward advancement of the Tuohy needle.	24 hours after delivery	No
Secondary	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	No
Secondary	Number of needle passes required for successful epidural catheterization		24 hours after delivery	No
Secondary	Number of skin punctures required for successful epidural catheterization		24 hours after delivery	No
Secondary	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	No
Secondary	Patient satisfaction (5-point scale)	5-point scale	24 hours after delivery	No
Secondary	Rate of Inadvertent dural puncture		24 hours after delivery	Yes
Secondary	Rate of Inadvertent vascular puncture		24 hours after delivery	Yes
Secondary	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	No
Secondary	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	No
Secondary	Rate of Back pain		24 hours after delivery	No