NCT02410226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

March 30, 2015

Last Update Submit

September 21, 2015

Conditions

Epidural AnesthesiaSpinal Ultrasound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Rate of successful epidural catheterization at the first skin puncture

    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

    24 hours after delivery

  • Patient satisfaction (5-point scale)

    24 hours after delivery

  • +5 more secondary outcomes

Other Outcomes (1)

  • Level of successful epidural catheterization

    24 hours after delivery

Study Arms (2)

Palpation

ACTIVE COMPARATOR

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

Procedure: Double-space combined spinal-epidural anesthesiaRadiation: Sham ultrasound procedure

Ultrasound

EXPERIMENTAL

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

Procedure: Double-space combined spinal-epidural anesthesiaRadiation: Preprocedure spinal ultrasound

Interventions

Double-space combined spinal-epidural anesthesiaPROCEDURE

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.

PalpationUltrasound
Preprocedure spinal ultrasoundRADIATION

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.

Ultrasound
Sham ultrasound procedureRADIATION

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.

Palpation

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Study Officials

  • Mohamed M Tawfik, M.Sc.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 7, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

EG(1)