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

Not Applicable
Completed
Conditions
Ultrasonography
Anesthesia, Spinal
Interventions
Procedure: Ultrasound-assisted paramedian technique spinal anesthesia
Procedure: Landmark-guided paramedian technique spinal anesthesia
Device: Ultrasound
Registration Number
NCT03316352
Lead Sponsor
Seoul National University Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ultrasound-assistedUltrasound-assisted paramedian technique spinal anesthesiaUltrasound-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.
Ultrasound-assistedUltrasoundUltrasound-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.
Landmark-guidedLandmark-guided paramedian technique spinal anesthesiaIn 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.
Landmark-guided0.5% heavy bupivacaineIn 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.
Ultrasound-assisted0.5% heavy bupivacaineUltrasound-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.
Primary Outcome Measures
NameTimeMethod
the number of needle passesfrom the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

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

Secondary Outcome Measures
NameTimeMethod
Periprocedural painfrom the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

11-point verbal rating scale (0=no pain, 10=most pain imaginable)

Number of spinal needle insertion attemptsfrom the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

the number of times the spinal needle was withdrawn from the skin and reinserted

Time for identifying landmarksfrom the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

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.

Time taken for performing spinal anestheticfrom the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

time from needle insertion to the completion of injection

Level of block5, 10, 15 minutes after the completion of spinal anesthetic injection

loss of cold sensation tested with 2% chlorhexidine swab

Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needlefrom the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle during the spinal anesthesia procedure

Periprocedural discomfort scorefrom the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection

11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)

Trial Locations

Locations (1)

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

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