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OpenTrials
Completed

NCT Number: NCT01680913

Does Ultrasound Guidance Improve Time to Perform a Spinal or Number of Attempts in Obese Patients?

Spinal anesthesia depends on being able to locate physical landmarks on a patient's body. In obese patients, the commonly used landmarks may be difficult or even impossible to feel. In addition, the spine can be hidden beneath a layer of fatty tissue.

Ultrasound is useful for finding the correct injection site in pregnant patients, but the usefulness of ultrasound has not been adequately evaluated in non-pregnant patients. The potential benefits for obese patients from the use of ultrasound include shortening the duration of the procedure, increasing patient comfort, decreasing the total number of attempts, and aiding in the choice of appropriate needle length for the patient.

The investigators hypothesize that there is no difference in time to perform a spinal anesthetic when landmarking with ultrasound as compared to tactile landmarking in patients with BMI > 35.

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Key information

Conditions

Spinal Anesthesia Administration

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Paul's Hospital, Saskatoon, Saskatchewan, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing surgeries amenable to spinal anesthetic
  • BMI >35
  • between the ages of 18-85

Exclusion criteria

  • Patients with known spinal disease or previous spinal surgery
  • Pregnant patients
  • Patients requiring emergent surgeries
  • Patients in positions other than sitting during neuroaxial anesthesia
  • Patients with contraindications to neuroaxial anesthesia

Treatment and study plan

Ultrasound guidance

Procedure

The intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views.

Palpation of Tuffier's line

Procedure

Current clinical practice. Standard of care would have the attending anesthetist palpate the Tuffier's line to pinpoint the appropriate location for the spinal.

Spinal anesthetic

Procedure

Subcutaneous local infiltration with a 25g needle we be performed prior to the spinal. Neuraxial technique will be attempted midline with a 25 gauge whitacre needle in the sitting position. Spinals will be attempted on either L2-L3, L3-L4, L4-L5 interspaces. The amount and type of local anesthetic/intrathecal narcotic will be left to the discretion of the Anesthetist.

Primary outcomes

  1. Total time to perform the spinal

    Time frame: From the beginning of palpation or ultrasound to free flow of Cerebral Spinal Fluid (CSF), up to 1 hour.

Secondary outcomes

  1. Time from administration of the local anesthetic needle until free flow CSF

    Time frame: Up to 1 hour

  2. Number of needle redirections

    Time frame: At time of spinal anesthetic administration

  3. Number of attempts to complete the spinal

    Time frame: At time of spinal anesthetic administration

    As measured by new needle puncture sites, according to the anesthetist performing the procedure

  4. Number of failed blocks

    Time frame: Up to 15 minutes after administration of spinal anesthesia

    Defined as unable to get free flow CSF or inadequate surgical block after administration of neuraxial anesthetic after 15 minutes.

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

Does Ultrasound Guidance Improve Time to Perform a Spinal or Number of Attempts in Obese Patients? A Randomized Controlled Study.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 7, 2012
Registry last updated
Nov 15, 2016

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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