This trial is active, not recruiting.

Condition orthopedic surgery-lower leg surgery
Treatment the anticholinergic glycopyrrolate 0.1 ㎎ + 0-15 mg hyperbaric bupivacaine
Sponsor Yonsei University
Start date December 2012
End date August 2014
Trial size 58 participants
Trial identifier NCT01768780, 4-2012-0692


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
This test group and the control group. Because within the group in two ways to check the level after spinal anesthesia will be.
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.

Primary Outcomes

Efficacy of peripheral nerve stimulator as checking sensory block level after spinal anesthesia
time frame: Changes of sensory block level at 5 minutes, 10 minutes, 15 minutes, 20 minutes after pinal anesthesia

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Yonsei University.