Efficacy of Peripheral Nerve Stimulator in Assessing Sensory Nerve Block Level of Spinal Anesthesia

Various methods are used to assess the level of anesthesia block after spinal anesthesia. Among them, ice cubes, alcohol swabs, and needles are commonly used in the clinical setting, but ice is limited by difficulties with management and transportation, and needle assessment has problems owing to the risk of pain, infection, and injury to the patient.

Hence, the alcohol swab is commonly used in practice. However, the absence of pain is more important in the surgical process, and assessing the pain block level is more feasible in practice than assessing the sensory nerve block level using the alcohol swab.

Therefore, it seems to be better to use the peripheral nerve stimulator for the accurate assessment of the pain block level. This has the advantage of continuous measurement of the block level, which can be used in a practical manner in conjunction with the surgical incision.

Hence, the author compared the conventional method using the alcohol swab with the use of the peripheral nerve stimulator to determine which method is more practical in the measurement of spinal anesthesia block level.

Study Overview

• Status: Unknown
• Conditions: Orthopedic Surgery-lower Leg Surgery
• Intervention / Treatment: Device: the anticholinergic glycopyrrolate 0.1 ㎎ + 0-15 mg hyperbaric bupivacaine

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Severance Hospital
    • Contact: Ki-Young Lee, MD; Phone Number: 02-2227-4224; Email: KYLEE504@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The study subjects were adult patients, 20-65 years old, who were going to have orthopedic surgery on the infrapatellar area with spinal anesthesia planned and who fell under the American Society of Anesthesiologist physical status classifications of 1 or 2.

Exclusion Criteria:

• Patients who could not read or understand the consent materials or who had pregnancy, hypertension, diabetes, a defect in blood coagulation, cardiovascular disease, or administration of cardiovascular medications were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: sensory nerve block level of spinal anesthesia; This test group and the control group. Because within the group in two ways to check the level after spinal anesthesia will be.

Device: the anticholinergic glycopyrrolate 0.1 ㎎ + 0-15 mg hyperbaric bupivacaine; The study subjects were patients with planned orthopedic surgery on the infrapatellar area with spinal anesthesia, and 58 patients were recruited sequentially. A blood pressure machine, electrocardiogram, and pulse oximeter were connected to the patient in the operating room, and measurements were carried out every 5 minutes. Prior to the induction of anesthesia, the anticholinergic glycopyrrolate 0.1 ㎎ was intravenously administered after the confirmation of intravenous line opening status. For spinal anesthesia, the patient was arranged in the lateral recumbent position, and then the L 3-4 area was disinfected. Depending on the surgical region, height, and weight of each patient, 10-15 mg hyperbaric bupivacaine was administered through a 25 G needle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of peripheral nerve stimulator as checking sensory block level after spinal anesthesia	The spinal anesthesia block levels were assessed and recorded using the alcohol swab and peripheral nerve stimulation, respectively.	Changes of sensory block level at 5 minutes, 10 minutes, 15 minutes, 20 minutes after pinal anesthesia

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: January 8, 2013
• First Submitted That Met QC Criteria: January 13, 2013
• First Posted (Estimate): January 15, 2013

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: spinal anesthesia; sensory block level; peripheral nerve stimulator
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Agents; Sensory System Agents; Anesthetics; Adjuvants, Anesthesia; Anesthetics, Local; Bupivacaine; Glycopyrrolate; Cholinergic Antagonists
• Other Study ID Numbers: 4-2012-0692