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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459105
• Other study ID #: 1801-107-917
• Status: Completed
• Phase: N/A
• Start date: March 13, 2018
• Est. completion date: July 5, 2018

Study information

• Verified date: January 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 5, 2018
• Est. primary completion date: July 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Scoliosis
• Ultrasonography

Intervention

Procedure:
• Ultrasound-assisted paramedian spinal anesthesia
A preprocedural ultrasound scanning will be done, and skin marking will be made. The needle entry point and insertion angle will be determined based on ultrasound scanning. Spinal anesthesia will be performed via paramedian approach.
• Landmark-guided spinal anesthesia
Spinal anesthesia will be done using conventional landmark-guided technique.

Drug:
• 0.5% heavy bupivacaine
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Chin KJ, Perlas A, Chan V, Brown-Shreves D, Koshkin A, Vaishnav V. Ultrasound imaging facilitates spinal anesthesia in adults with difficult surface anatomic landmarks. Anesthesiology. 2011 Jul;115(1):94-101. doi: 10.1097/ALN.0b013e31821a8ad4. — View Citation

Outcome

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