Spinal Anesthesia Administration Clinical Trial
Official title:
Does Ultrasound Guidance Improve Time to Perform a Spinal or Number of Attempts in Obese Patients? A Randomized Controlled Study.
| Verified date | November 2016 |
| Source | University of Saskatchewan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 67 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Canada | Saint Paul's Hospital | Saskatoon | Saskatchewan |
| Canada | Saskatoon City Hospital | Saskatoon | Saskatchewan |
| Lead Sponsor | Collaborator |
|---|---|
| University of Saskatchewan |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No | |
| Secondary | Time from administration of the local anesthetic needle until free flow CSF | Up to 1 hour | No | |
| Secondary | Number of needle redirections | At time of spinal anesthetic administration | No | |
| Secondary | Number of attempts to complete the spinal | As measured by new needle puncture sites, according to the anesthetist performing the procedure | At time of spinal anesthetic administration | No |
| Secondary | Number of failed blocks | Defined as unable to get free flow CSF or inadequate surgical block after administration of neuraxial anesthetic after 15 minutes. | Up to 15 minutes after administration of spinal anesthesia | No |