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

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Ultrasonography
Anesthesia, Spinal

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03316352
1708-113-879

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Ultrasound-assisted
Experimental group
Description:
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.
Treatment:
Procedure: Ultrasound-assisted paramedian technique spinal anesthesia
Device: Ultrasound
Drug: 0.5% heavy bupivacaine
Landmark-guided
Active Comparator group
Description:
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.
Treatment:
Procedure: Landmark-guided paramedian technique spinal anesthesia
Drug: 0.5% heavy bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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