Ultrasound-assisted Versus Conventional Landmark-guided Paramedian Spinal Anesthesia in Elderly Patients

Study Overview
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Brief Summary
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Multiple passes and attempts during spinal anesthesia might be associated with a greater incidence of paraesthesia, postdural puncture headache, and spinal hematoma. We hypothesized that the use of a preprocedural ultrasound-assisted paramedian technique for spinal anesthesia in patients with old age would reduce the number of passes required to entry into the subarachnoid space when compared with the landmark-guided paramedian approach. The study participants will be randomized into group L (landmark-guided) and group U (ultrasound-assisted). In group L, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. In group U, a preprocedural ultrasound scan will be used to mark the needle insertion site, and spinal anesthetic will be done via the paramedian approach.

Official Title
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Ultrasound-assisted Versus Conventional Landmark-guided Paramedian Spinal Anesthesia in Elderly Patients

Conditions
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Anesthesia, Spinal, Ultrasonography

Intervention / Treatment
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* Procedure: Ultrasound-assisted paramedian technique spinal anesthesia
* Procedure: Landmark-guided paramedian technique spinal anesthesia
* Device: Ultrasound
* Drug: 0.5% heavy bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elderly patients (age≥60 years) scheduled to undergoing elective orthopedic surgery under spinal anesthesia Patients with ASA physical status classification I, II, III Exclusion Criteria: Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic) Patients with morbid cardiac diseases Pregnancy Patients with previous history of lumbar spine surgery

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound-assisted<br>Ultrasound-assisted paramedian technique spinal anesthesia will be performed. A Preprocedural ultrasound scan will be performed for skin marking of entry site of spinal needle. Spinal anesthesia will be performed via paramedian approach using the skin marking site as entry point. 0.5% heavy bupivacaine will be administered into intrathecal space. | Procedure: Ultrasound-assisted paramedian technique spinal anesthesia<br>* Ultrasound-assisted paramedian technique will be used. A preprocedural ultrasound scan will be performed, and skin marking for spinal entry site will be done using ultrasound scan. Spinal anesthesia will be done according to skin marking using ultrasound, via paramedian approach.<br>* Other names: sono-assisted;Device: Ultrasound<br>* A preprocedural ultrasound scan will be done using Portable Echocardiography system (Vivid-i, GE healthcare) with 4C-RS convex probe (2.0-5.5 MHz Frequency range).<br>* Other names: sonography;Drug: 0.5% heavy bupivacaine<br>* During spinal anesthesia, 0.5% heavy bupivacaine will be administered into intrathecal space. The dose of local anesthetic injected for spinal anesthesia will be at the discretion of the attending anesthesiologist. The dose range of intrathecal bupivacaine will be between 12 and 16 mg.<br>* Other names: bupivacaine;|
| Active Comparator: Landmark-guided<br>In these patients, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. Landmark-guided paramedian technique spinal anesthesia will be performed. 0.5% heavy bupivacaine will be administered into intrathecal space. | Procedure: Landmark-guided paramedian technique spinal anesthesia<br>* Landmark-guided paramedian technique will be used. Spinal anesthesia will be done using conventional landmark-guided paramedian technique.<br>* Other names: conventional;Drug: 0.5% heavy bupivacaine<br>* During spinal anesthesia, 0.5% heavy bupivacaine will be administered into intrathecal space. The dose of local anesthetic injected for spinal anesthesia will be at the discretion of the attending anesthesiologist. The dose range of intrathecal bupivacaine will be between 12 and 16 mg.<br>* Other names: bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of needle passes | the number of forward advancements of the spinal needle in a given interspinous space, i.e., withdrawal and redirection of spinal needle without exiting the skin | from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of spinal needle insertion attempts | the number of times the spinal needle was withdrawn from the skin and reinserted | from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection | 
| Time for identifying landmarks | In group L, time from start of palpation to completion of the process, as declared by the anesthesiologist. In group U, time from placement of the ultrasound probe on the skin to the completion of markings. | from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection | 
| Time taken for performing spinal anesthetic | time from needle insertion to the completion of injection | from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection | 
| Level of block | loss of cold sensation tested with 2% chlorhexidine swab | 5, 10, 15 minutes after the completion of spinal anesthetic injection | 
| Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle | Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle during the spinal anesthesia procedure | from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection | 
| Periprocedural pain | 11-point verbal rating scale (0=no pain, 10=most pain imaginable) | from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection | 
| Periprocedural discomfort score | 11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable) | from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection |