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

NCT01680913 | Completed

• 1 other identifier: U/S spinals
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Spinal Anesthesia Administration

Outcome Measures

Primary Outcomes (1)

• Total time to perform the spinal

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

Secondary Outcomes (4)

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

  Up to 1 hour

• Number of needle redirections

  At time of spinal anesthetic administration

• Number of attempts to complete the spinal

  At time of spinal anesthetic administration

• Number of failed blocks

  Up to 15 minutes after administration of spinal anesthesia

Study Arms (2)

Spinal with ultrasound guidance

EXPERIMENTAL

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

Procedure: Ultrasound guidance; Procedure: Spinal anesthetic

Spinal by palpation of Tuffier's line

ACTIVE COMPARATOR

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

Procedure: Palpation of Tuffier's line; Procedure: Spinal anesthetic

Interventions

Ultrasound guidance PROCEDURE

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

Spinal with ultrasound guidance

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 by palpation of Tuffier's line

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.

Spinal by palpation of Tuffier's line; Spinal with ultrasound guidance

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (2)

Saskatoon City Hospital

Saskatoon, Saskatchewan, S7K 0M7, Canada

Location

Saint Paul's Hospital

Saskatoon, Saskatchewan, S7M 0Z9, Canada

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Jacelyn Larson, MD FRCP

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: September 7, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

CA (2)