The Effect of Warm Local Anesthetic Solution on Epidural Anesthesia

NCT ID: NCT03860402

Last Updated: 2020-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-01-31

Brief Summary

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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

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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

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Cesarean Section

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Temperature

Intervention Type OTHER

temperature of drug

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.

No interventions assigned to this group

Interventions

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Temperature

temperature of drug

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Among the pregnant women who were administered cesarean section in this study, those who agreed to participate in this study.

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hallym University Kangnam Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Choi Eun MI

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eun Mi Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Hallym University Kangnam Sacred Heart Hospital

Locations

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Kangnam sacred heart hospital

Seoul, Yeongdeungpo-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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kangnamANE

Identifier Type: -

Identifier Source: org_study_id

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