Cesarean SectionNCT03860402
The Effect of Warm Local Anesthetic Solution on Epidural Anesthesia
An observational study of Cesarean Section, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The investigators are going to compare the onset and duration of nerve blockage with the use of pre-warmed (38°C) and room temperature (20°C) local anesthetic solutions (ropivacaine and fentanyl) on epidural anesthesia for cesarean section, and compare the incidence of complications such as hypotension, nausea and… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Temperature
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2019to 31 Jan 2020
- Phase
- Observational
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Among the pregnant women who were administered cesarean section in this study, those who agreed to participate in this study.
Who may be able to join
- Among the pregnant women who were administered cesarean section in this study, those who agreed to participate in this study.
Who cannot join
- Fetal distress requiring fast delivery.
- Patients with hypersensitivity, allergic response, resistance to the drugs used in this study (fentanyl, ropivacaine, lidocaine).
- Patients who is not possible for regional anesthesia
- Patients who refused to participate in this study.
- Patients who cannot read or understand the agreement.
- Patients whose weight is less than 50kg or exceeds 100kg.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kangnam sacred heart hospital
Seoul, Yeongdeungpo-gu, KS013
About this study
Official title: The Effect of Warm Local Anesthetic Solution for Sensory Block on Epidural Anesthesia of Cesarean Delivery : a Randomized Controlled Study
The investigators are going to compare the onset and duration of nerve blockage with the use of pre-warmed (38°C) and room temperature (20°C) local anesthetic solutions (ropivacaine and fentanyl) on epidural anesthesia for cesarean section, and compare the incidence of complications such as hypotension, nausea and vomiting.
Read the detailed description
Spinal anesthesia has a shorter time to onset than epidural anesthesia, and the amount of local anesthetic administered is lower than that of epidural anesthesia, resulting in less systemic toxicity and superior block effect.
However, there are disadvantage that it is difficult to control the block height and the incidence of hypotension is high.
On the other hand, epidural anesthesia has the advantages of less sudden hypotension due to slow autonomic blockade, but it has a disadvantage that sensory nerve and motor nerve block time is delayed compared to spinal anesthesia.
The degree of nerve block for cesarean section surgery requires a high level of anesthesia above the T6 level, so the frequency of hypotension is high due to rapid sympathetic block after spinal anesthesia.
In this respect, hemodynamically stable epidural anesthesia is preferred when performing anesthesia for cesarean section.
The investigators are going to compare the onset and duration of nerve blockage with the use of pre-warmed (38°C) and room temperature (20°C) local anesthetic solutions (ropivacaine and fentanyl) on epidural anesthesia for cesarean section, and compare the incidence of complications such as hypotension, nausea and vomiting.
- Conditions
- Cesarean Section
- Being tested
- Temperature
- Keywords
- pre-warmed epiural anesthetics, epidural anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemperatureOther
temperature of drug
| Study group | Role | What they receive |
|---|---|---|
| Pre-warmed drug | Pre-warmed (38°C) ropivacaine (7.5mg/ml) 19ml and fentanyl 50ug are injected via the epidural route at the L3-4 interspace. Receives: Other: Temperature | |
| Room temperature drug | Room temperature (20°C) ropivacaine (7.5mg/ml) 19ml and fentanyl 50ug are injected via the epidural route at the L3-4 interspace. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time of epidural anesthesia (up to T6 level)
After the administration of epidural local anesthetics the sensory block level is checked every 2 minutes for 20 minutes, every 10 minutes during operating period, and every 10 minutes for 60 minutes in the recovery room. The sensory block level is assessed using the pinprick test method.
Measured: During the operation
Secondary outcomes (2)
Incidence of hypotension
When systolic blood pressure is less than 90 mmHg or mean arterial pressure is less than 60 mmHg, 30 mcg of phenylephrine is administrated. If bradycardia(HR<50) is accompanied, 4mg of ephedrine is injected.
Measured: During the operation
Incidence of nausea and vomiting
Record the nausea and vomiting that occurred in the operating room and in the recovery room after administration of the local anesthetic. If there is nausea and vomiting after surgery, ramosetron (0.3mg) should be administered if the postoperative nausea and vomiting(PONV) grade is 1 or more and symptoms are severe enough to require medication.
Measured: From the time of epidural injection to 1 hour after entering recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Feb 2019
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Choi Eun MI, Hallym University Kangnam Sacred Heart Hospital
- Investigators
- Eun Mi Choi, MD, Principal investigator, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860402
- Sponsor's protocol ID
- kangnamANE
- Status last verified
- Mar 2020
- First submitted
- 25 Jan 2019
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Warm Local Anesthetic Solution for Sensory Block on Epidural Anesthesia of Cesarean Delivery : a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03860402
- Acronym / sponsor ID
- kangnamANE
- Conditions
- Cesarean Section
- Keywords
- pre-warmed epiural anesthetics, epidural anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 1 Mar 2019 (actual)
- 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.
The investigators are going to compare the onset and duration of nerve blockage with the use of pre-warmed (38°C) and room temperature (20°C) local anesthetic solutions (ropivacaine and fentanyl) on epidural anesthesia for cesarean section, and compare the incidence of complications such as hypotension, nausea and vomiting.
Detailed description
Spinal anesthesia has a shorter time to onset than epidural anesthesia, and the amount of local anesthetic administered is lower than that of epidural anesthesia, resulting in less systemic toxicity and superior block effect.
However, there are disadvantage that it is difficult to control the block height and the incidence of hypotension is high.
On the other hand, epidural anesthesia has the advantages of less sudden hypotension due to slow autonomic blockade, but it has a disadvantage that sensory nerve and motor nerve block time is delayed compared to spinal anesthesia.
The degree of nerve block for cesarean section surgery requires a high level of anesthesia above the T6 level, so the frequency of hypotension is high due to rapid sympathetic block after spinal anesthesia.
In this respect, hemodynamically stable epidural anesthesia is preferred when performing anesthesia for cesarean section.
The investigators are going to compare the onset and duration of nerve blockage with the use of pre-warmed (38°C) and room temperature (20°C) local anesthetic solutions (ropivacaine and fentanyl) on epidural anesthesia for cesarean section, and compare the incidence of complications such as hypotension, nausea and vomiting.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-warmed drug | – | Other: TemperaturePre-warmed (38°C) ropivacaine (7.5mg/ml) 19ml and fentanyl 50ug are injected via the epidural route at the L3-4 interspace. |
| Room temperature drug | – | –Room temperature (20°C) ropivacaine (7.5mg/ml) 19ml and fentanyl 50ug are injected via the epidural route at the L3-4 interspace. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Among the pregnant women who were administered cesarean section in this study, those who agreed to participate in this study.
Key inclusion criteria (1 listed)
- Among the pregnant women who were administered cesarean section in this study, those who agreed to participate in this study.
Key exclusion criteria (6 listed)
- Fetal distress requiring fast delivery.
- Patients with hypersensitivity, allergic response, resistance to the drugs used in this study (fentanyl, ropivacaine, lidocaine).
- Patients who is not possible for regional anesthesia
- Patients who refused to participate in this study.
- Patients who cannot read or understand the agreement.
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 |
|---|---|---|
| Temperaturetemperature of drug | Other | Pre-warmed drug |
Primary outcome
Onset time of epidural anesthesia (up to T6 level)
Time frame: During the operation
After the administration of epidural local anesthetics the sensory block level is checked every 2 minutes for 20 minutes, every 10 minutes during operating period, and every 10 minutes for 60 minutes in the recovery room. The sensory block level is assessed using the pinprick test method.
2 secondary outcomes
Incidence of hypotension
Time frame: During the operation
Incidence of nausea and vomiting
Time frame: From the time of epidural injection to 1 hour after entering recovery room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
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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.
Eun Mi Choi, MD principal investigator
Hallym University Kangnam Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section, run by Hallym University Kangnam Sacred Heart Hospital 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 6 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: finished, as of the sponsor's last update on 6 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset time of epidural anesthesia (up to T6 level) (time frame: During the operation). 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 6 Mar 2020.