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Completed

NCT Number: NCT01865955

Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia

Pre-procedural ultrasound for Spinal & Epidural anesthesia is now being increasingly performed worldwide. Pre-procedural ultrasound assessment of the spine has been shown to facilitate the placement of epidural anesthesia in pregnant women, diagnostic lumbar punctures, performance of spinal anesthesia in non-obstetric patients and accurate identification of the interspace at which the puncture is being performed. This is especially important during spinal anesthesia, where puncture below the ending of the spinal cord is recommended for safety.

The purpose of this study is to compare the performance of spinal anesthesia between the pre-procedural ultrasound assessment of the spine and the traditional palpatory technique, in term pregnant women undergoing elective cesarean delivery. Furthermore, we aim to describe sonoanatomic features of the spine that could predict the ease of insertion of spinal anesthesia in that patient population.

We hypothesize that in term pregnant women undergoing elective cesarean delivery, pre-procedural ultrasound assessment of the spine will improve the success rate of spinal anesthesia at first attempt, compared to the traditional palpatory technique.

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Key information

Conditions

Pregnancy

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnant patients scheduled to receive spinal anesthesia for elective cesarean sections
  • ASA physical status 1 - 3
  • Written informed consent
  • Gestational age ≥ 37 weeks.

Exclusion criteria

  • Patient's refusal.
  • Body mass index ≥ 45
  • Patient with marked spinal bony deformity (Severe scoliosis on visual inspection and previous spinal instrumentation).

Treatment and study plan

Ultrasound

Procedure

Ultrasound applied to the lumbar region to determine spinal needle placement.

The spinal needle

Device

Primary outcomes

  1. Spinal needle redirections

    Time frame: 15 minutes

    Number of redirections needed to perform a successful spinal puncture (presence of cerebrospinal fluid). A needle redirection is defined as any change in needle insertion trajectory that did not involve complete withdrawal of the needle from the patient's skin. The first needle pass will not be considered a redirection.

Secondary outcomes

  1. Needle reinsertions

    Time frame: 15 minutes

    Number of needle reinsertions defined as complete withdrawal of the spinal needle to the patient's skin followed by a new attempt in the same interspace.

  2. Need to change to another interspace.

    Time frame: 15 minutes

    Relocating the spinal needle to another interspace.

  3. Procedure time

    Time frame: 15 minutes

    Time taken to perform the spinal anesthesia, measured from insertion of the introducer needle to visualization of spinal fluid.

  4. Pain score

    Time frame: 15 minutes

    Verbal Numerical Pain Scores during the procedure (0-10, where 0 means no pain and 10 mean the worst pain imaginable).

  5. Intervertebral level agreement

    Time frame: 3 hours

    Intervertebral level agreement between L3-L4 obtained in the postoperative ultrasound assessment and the marked intervertebral level obtained pre-procedure, either by ultrasound or palpation.

  6. Ultrasound Grading

    Time frame: 3 hours

    Ultrasound Grading: The image pattern of the intervertebral space will be categorized into three grades by three study investigators not involved in providing the spinal anesthesia: Typical Image,Atypical Image or Inconclusive Image.

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia in Term Parturients Undergoing Elective Caesarian Section- A Randomized Control Trial

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 31, 2013
Registry last updated
Feb 3, 2014

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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