Clinical trial NCT03860402: The Effect of Warm Local Anesthetic Solution on Epidural Anesthesia
Official title: The Effect of Warm Local Anesthetic Solution for Sensory Block on Epidural Anesthesia of Cesarean Delivery : a Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Keywords: pre-warmed epiural anesthetics
epidural anesthesia
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Among the pregnant women who were administered cesarean section in this study, those who agreed to participate in this study.

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Onset time of epidural anesthesia (up to T6 level)
timeFrame: During the operation
Secondary outcomes:
measure: Incidence of hypotension
timeFrame: During the operation
measure: Incidence of nausea and vomiting
timeFrame: From the time of epidural injection to 1 hour after entering recovery room
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam sacred heart hospital
state: Yeongdeungpo-gu
Study officials:
affiliation: Hallym University Kangnam Sacred Heart Hospital
name: Eun Mi Choi, MD
role: PRINCIPAL_INVESTIGATOR
References: