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

Ultrasonography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316352
• Other study ID #: 1708-113-879
• Status: Completed
• Phase: N/A
• Start date: October 24, 2017
• Est. completion date: January 11, 2018

Study information

• Verified date: August 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 11, 2018
• Est. primary completion date: January 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Ultrasonography

Intervention

Procedure:
• Ultrasound-assisted paramedian technique spinal anesthesia
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.
• Landmark-guided paramedian technique spinal anesthesia
Landmark-guided paramedian technique will be used. Spinal anesthesia will be done using conventional landmark-guided paramedian technique.

Device:
• Ultrasound
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).

Drug:
• 0.5% heavy bupivacaine
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.

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 (2)

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

Kallidaikurichi Srinivasan K, Iohom G, Loughnane F, Lee PJ. Conventional Landmark-Guided Midline Versus Preprocedure Ultrasound-Guided Paramedian Techniques in Spinal Anesthesia. Anesth Analg. 2015 Oct;121(4):1089-96. doi: 10.1213/ANE.0000000000000911. — 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	from the initiation of spinal anesthesia procedure, 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	from the initiation of spinal anesthesia procedure, 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.	from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
Secondary	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
Secondary	Level of block	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	from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
Secondary	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
Secondary	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