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

NCT ID: NCT01768780

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2020-05-31

Brief Summary

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.

Conditions

Orthopedic Surgery-lower Leg Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

the anticholinergic glycopyrrolate 0.1 ㎎ + 0-15 mg hyperbaric bupivacaine

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Ki-Young Lee, MD

Role: CONTACT

KYLEE504@yuhs.ac

02-2227-4224

Facility Contacts

Ki-Young Lee, MD

Role: primary

KYLEE504@yuhs.ac

02-2227-4224

Other Identifiers

4-2012-0692

Identifier Type: -

Identifier Source: org_study_id