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

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.

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Anesthesia, Spinal
• Intervention / Treatment: Procedure: Ultrasound-assisted paramedian technique spinal anesthesia; Device: Ultrasound; Drug: 0.5% heavy bupivacaine; Procedure: Landmark-guided paramedian technique spinal anesthesia

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound-assisted; 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.	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.; Other Names: sono-assisted; 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).; Other Names: sonography; 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.; Other Names: bupivacaine
Active Comparator: Landmark-guided; 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.	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.; Other Names: bupivacaine; Procedure: Landmark-guided paramedian technique spinal anesthesia; Landmark-guided paramedian technique will be used. Spinal anesthesia will be done using conventional landmark-guided paramedian technique.; Other Names: conventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Level of block	loss of cold sensation tested with 2% chlorhexidine swab	5, 10, 15 minutes after the completion of spinal anesthetic injection
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
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
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• 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.
• 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):1089-1096. doi: 10.1213/ANE.0000000000000911.
• Park SK, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-assisted vs. landmark-guided paramedian spinal anaesthesia in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):763-771. doi: 10.1097/EJA.0000000000001029.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2017
• Primary Completion (Actual): January 11, 2018
• Study Completion (Actual): January 11, 2018

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Local; Anesthetics; Bupivacaine
• Other Study ID Numbers: 1708-113-879

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No