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NCT Number: NCT02410226

Ultrasound Versus Palpation for Epidural Catheterization

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.

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Key information

Conditions

Epidural Anesthesia Spinal Ultrasound

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Double-space combined spinal-epidural anesthesia

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

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.

Sham Ultrasound Procedure

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.

Primary outcomes

  1. Rate of successful epidural catheterization at the first needle pass

    Time frame: 24 hours after delivery

    Needle pass includes any forward advancement of the Tuohy needle.

Secondary outcomes

  1. Rate of successful epidural catheterization at the first skin puncture

    Time frame: 24 hours after delivery

    Skin puncture includes any separate skin puncture by the Tuohy needle.

  2. Number of needle passes required for successful epidural catheterization

    Time frame: 24 hours after delivery

  3. Number of skin punctures required for successful epidural catheterization

    Time frame: 24 hours after delivery

  4. Time of the epidural catheterization procedure

    Time frame: 24 hours after delivery

    From the initial Tuohy needle insertion through the skin to the completion of the threading of the epidural catheter.

  5. Patient satisfaction (5-point scale)

    Time frame: 24 hours after delivery

    5-point scale

  6. Rate of Inadvertent dural puncture

    Time frame: 24 hours after delivery

  7. Rate of Inadvertent vascular puncture

    Time frame: 24 hours after delivery

  8. Rate of Failed block

    Time frame: 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.

  9. Unilateral / Patchy block (Assessed by pinprick)

    Time frame: 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

  10. Rate of Back pain

    Time frame: 24 hours after delivery

Other outcomes

  1. Level of successful epidural catheterization

    Time frame: 24 hours after delivery

    The lumbar intervertebral space L 2-3 or 3-4 used for epidural catheter insertion.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2015
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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