Orthopedic Surgery-lower Leg SurgeryNCT01768780
Efficacy of Peripheral Nerve Stimulator in Assessing Sensory Nerve Block Level of Spinal Anesthesia
A study testing the anticholinergic glycopyrrolate 0.1 ㎎ + 0-15 mg hyperbaric bupivacaine in people with Orthopedic Surgery-lower Leg Surgery, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Surgery-lower Leg Surgery
- What is being tested?
- the anticholinergic glycopyrrolate 0.1 ㎎ + 0-15 mg hyperbaric bupivacaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance hospital
Seoul, 120-752
Ki-Young Lee, MD, 02-2227-4224, KYLEE504@yuhs.ac
About this study
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.
Read more
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
- Being tested
- the anticholinergic glycopyrrolate 0.1 ㎎ + 0-15 mg hyperbaric bupivacaine
- Keywords
- spinal anesthesia, peripheral nerve stimulator, sensory block level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the anticholinergic glycopyrrolate 0.1 ㎎ + 0-15 mg hyperbaric bupivacaineDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| sensory nerve block level of spinal anesthesia | Experimental | This test group and the control group. Because within the group in two ways to check the level after spinal anesthesia will be. Receives: Device: the anticholinergic glycopyrrolate 0.1 ㎎ + 0-15 mg hyperbaric bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes of sensory block level at 5 minutes, 10 minutes, 15 minutes, 20 minutes after pinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic Surgery-lower Leg SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768780
- Sponsor's protocol ID
- 4-2012-0692
- Status last verified
- Mar 2019
- First submitted
- 8 Jan 2013
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Peripheral Nerve Stimulator in Assessing Sensory Nerve Block Level of Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT01768780
- Acronym / sponsor ID
- 4-2012-0692
- Conditions
- Orthopedic Surgery-lower Leg Surgery
- Keywords
- spinal anesthesia, peripheral nerve stimulator, sensory block level
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 15 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sensory nerve block level of spinal anesthesia | Experimental | Device: the anticholinergic glycopyrrolate 0.1 ㎎ + 0-15 mg hyperbaric bupivacaineThis test group and the control group. Because within the group in two ways to check the level after spinal anesthesia will be. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the anticholinergic glycopyrrolate 0.1 ㎎ + 0-15 mg hyperbaric bupivacaineThe 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. | Device | sensory nerve block level of spinal anesthesia |
Primary outcome
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
The spinal anesthesia block levels were assessed and recorded using the alcohol swab and peripheral nerve stimulation, respectively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the anticholinergic glycopyrrolate 0.1 ㎎ + 0-15 mg hyperbaric bupivacaine in people with Orthopedic Surgery-lower Leg Surgery, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ki-Young Lee, MD (02-2227-4224, KYLEE504@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.