Spinal Anesthesia in Patients With Poorly-palpable Surface Landmarks

NCT ID: NCT03377764

Last Updated: 2017-12-19

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-05-31

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.

Detailed Description

Neuraxial blockade has traditionally been accomplished using a surface landmark-guided technique, in which the approximate location of the neuraxial midline, lumbar interspinous and interlaminar spaces are determined based on palpation of the intercristal line and the tips of the spinous processes. It is not surprising, therefore, that the technical difficulty of neuraxial blockade (usually measured in terms of the number of needle passes required for success) correlates with the quality of palpable surface landmarks.

Reducing the technical difficulty of neuraxial blockade is desirable as multiple needle insertion attempts may increase the risk of complications such as post-dural puncture headache, paresthesiae, and epidural hematoma. Ultrasound (US) imaging of the spine can help in this regard by more precisely identifying landmarks, determining the intervertebral level, and measuring the depth to the epidural space. It has been shown to facilitate the performance of neuraxial block in the obstetric population, and our group has also demonstrated similar benefits in the older non-obstetric population. In a feasibility study of US-guided spinal anesthesia for total joint replacement surgery, achieved successful spinal anesthesia with a single needle insertion attempt in 84% of these patients, despite the fact that nearly half of them had poorly palpable surface landmarks.This compares well with large prospective cohort studies which report successful neuraxial blockade on the first needle insertion attempt in 61-64% of all patients. Investigators recently completed a randomized controlled trial in which 120 patients with difficult anatomical landmarks (defined as poorly palpable surface landmarks and a BMI>35 kgm-2, significant spinal deformity, or spinal surgery resulting in distortion or absence of surface landmarks) received spinal anesthesia performed by experienced anesthesiologists using either a conventional surface landmark-guided technique or an US-guided technique. There was a two-fold difference between the US-guided group and the control group in the first-attempt success rate (62% vs 32%, P<0.001), and the median number of needle passes required for success (6 vs 13, P=0.003).

The main limitation of all clinical studies conducted to date on US-guided neuraxial block is that ultrasound imaging was performed solely by experienced operators; although in two studies the neuraxial block itself (but not the ultrasound scan) was performed by trainees.

Investigators believe that the benefits of the US-guided technique can be realized when it is performed in its entirety by novices, e.g. anesthesia trainees. Investigators therefore designed this study to establish if novices are able to use the US-guided technique to facilitate the performance of spinal anesthesia in obese patients with poorly-palpable landmarks.

Conditions

Regional Anesthesia

Keywords

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Landmark Technique

Control group

Landmark Technique Control group

Intervention Type: PROCEDURE

Spinal Anesthetic

Ultrasound guided technique

Neuroaxial block using Ultrasound guidance

Neuroaxial block using Ultrasound Guidance

Intervention Type: PROCEDURE

Ultrasound guided Spinal Anesthetic

Interventions

Landmark Technique Control group

Spinal Anesthetic

Intervention Type: PROCEDURE

Neuroaxial block using Ultrasound Guidance

Ultrasound guided Spinal Anesthetic

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Toronto Western Hopspital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

11-0054-A

Identifier Type: -

Identifier Source: org_study_id