Spinal Anesthesia in Patients With Poorly-palpable Surface Landmarks

NCT03377764 | Terminated DMC

• 1 other identifier: 11-0054-A
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Anesthesia trainees can perform spinal anesthesia in patients who have poorly-palpable surface landmarks with fewer needle passes using an ultrasound-guided technique compared to the conventional surface landmark-guided technique.

Conditions

Regional Anesthesia

Keywords

Spinal Anesthetic,; Ultrasound guided Neuroaxial block,; Anesthesia Trainees

Outcome Measures

Primary Outcomes (1)

• The rate of successful dural puncture on the first needle insertion attempt.

  Insertion attempts are defined as complete withdrawal of the needle or introducer from the skin followed by re-insertion, and are distinguished from redirection attempts, which are defined as changes in needle trajectory that do not involve complete withdrawal of the needle from the skin. 1,2.14,15 This will be assessed by two blinded observers from an anonymized video recording of the operator's hands as they perform the spinal anesthetic.

  2012-2013

Secondary Outcomes (3)

• The total number of needle passes required for dural puncture.

  2012-2013

• Block performance time

  2012-2013

• Time taken to perform spinal anesthetic

  2012-2013

Study Arms (2)

Landmark Technique

Control group

Procedure: Landmark Technique Control group

Ultrasound guided technique

Neuroaxial block using Ultrasound guidance

Procedure: Neuroaxial block using Ultrasound Guidance

Interventions

Landmark Technique Control group PROCEDURE

Spinal Anesthetic

Landmark Technique

Neuroaxial block using Ultrasound Guidance PROCEDURE

Ultrasound guided Spinal Anesthetic

Ultrasound guided technique

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit patients presenting for elective total hip or knee replacement under spinal anesthesia, who have poorly palpable or impalpable spinous processes and a body mass index (BMI) ≥ 35 kgm-2. Exclusion criteria include inability or refusal to provide informed consent, bleeding diathesis, allergy to local anesthetics, or any other contra-indication to spinal anesthesia. Criteria for withdrawal after enrolment will include cancellation of surgery, unavailability of personnel with the requisite experience to perform the ultrasound-guided technique, and patient refusal to participate or continue with the study at any point up to completion of the US scan.

You may qualify if:

• Patients presenting for elective total hip or knee replacement under spinal anesthesia who have poorly palpable or impalpable spinous processes
• BMI ≥ 35 kgm-2

You may not qualify if:

• Inability or refusal to provide informed consent,
• Bleeding diathesis,
• Allergy to local anesthetics
• Contra-indication to spinal anesthesia

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hopspital

Toronto, Ontario, M5T2S8, Canada

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: December 19, 2017
• Study Start: August 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 19, 2017

Record last verified: 2011-05

Locations

CA (1)