Ultrasound Versus Palpation for Epidural Catheterization

NCT ID: NCT02410226

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-09-30

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.

Conditions

Epidural Anesthesia; Spinal Ultrasound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Palpation

Double-space combined spinal-epidural anesthesia, Sham ultrasound procedure

Group Type: ACTIVE_COMPARATOR

Double-space combined spinal-epidural anesthesia

Intervention Type: PROCEDURE

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.

Sham ultrasound procedure

Intervention Type: RADIATION

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.

Ultrasound

Double-space combined spinal-epidural anesthesia, Preprocedure spinal ultrasound

Group Type: EXPERIMENTAL

Double-space combined spinal-epidural anesthesia

Intervention Type: PROCEDURE

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.

Preprocedure spinal ultrasound

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: 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.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Mohamed Tawfik

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed M Tawfik, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Surgical Intensive Care, Mansoura University Hospitals.

Locations

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

R115

Identifier Type: -

Identifier Source: org_study_id