Ultrasound-assisted Versus Conventional Landmark-guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy

Not Applicable

Completed

• Conditions: Ultrasonography; Scoliosis; Anesthesia, Spinal
• Interventions: Procedure: Ultrasound-assisted paramedian spinal anesthesia; Procedure: Landmark-guided spinal anesthesia; Drug: 0.5% heavy bupivacaine

• Registration Number: NCT03459105
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Spinal anesthesia can be challenging in patients with lumbar scoliosis or previous lumbar spine surgery. This study aims to evaluate whether the use of the ultrasound-assisted spinal anesthesia reduces the number of passes required to successful dural puncture compared with the conventional surface landmark-guided technique in patients with abnormal spinal anatomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-08
• Study Start: 2018-03-13
• Primary Completion: 2018-07-04
• Study Completion: 2018-07-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Adult patients scheduled to undergoing elective orthopedic surgery under spinal anesthesia,

• with ASA physical status classification I, II, III,

• and with (1) or (2)

  1. documented scoliosis in preoperative L-S-Spine X-ray (Cobb abgle > 10 degree)
  2. previous history of lumbar spinal surgery

Exclusion Criteria

• Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)
• Patients with morbid cardiac diseases
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound-assisted	Ultrasound-assisted paramedian spinal anesthesia	Preprocedural ultrasound-assisted paramedian spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
Ultrasound-assisted	0.5% heavy bupivacaine	Preprocedural ultrasound-assisted paramedian spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
Landmark-guided	Landmark-guided spinal anesthesia	Landmark-guided spinal anesthesia will be performed, via either midline or paramedian approach. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
Landmark-guided	0.5% heavy bupivacaine	Landmark-guided spinal anesthesia will be performed, via either midline or paramedian approach. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.

Primary Outcome Measures

Name	Time	Method
the number of needle passes	Intraoperative (from the first insertion of needle to patient's skin, 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

Name	Time	Method
Periprocedural pain	Patients will be asked immediately after the completion of spinal anesthesia	11-point verbal rating scale (0=no pain, 10=most pain imaginable)
Time taken for performing spinal anesthetic	Intraoperative (from insertion of the needle to the completion of injection)	time from needle insertion to the completion of injection
dermatome level of sensory block	5, 10, 15 minutes after the completion of spinal anesthetic injection	thoracic dermatome level of sensory block assessed by loss of cold sensation tested with 2% chlorhexidine swab
Periprocedural discomfort score	Patients will be asked immediately after the completion of spinal anesthesia	11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)
Number of spinal needle insertion attempts	Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)	the number of times the spinal needle was withdrawn from the skin and reinserted
Time for identifying landmarks	1 day (time taken for establish the landmark, from start of palpation/US scanning to completion of palpation/scanning)	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.
Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle	Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection)	Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle during the spinal anesthesia procedure

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of