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Clinical Trials/NCT03860402
NCT03860402
Completed
Not Applicable

The Effect of Warm Local Anesthetic Solution for Sensory Block on Epidural Anesthesia of Cesarean Delivery : a Randomized Controlled Study

Hallym University Kangnam Sacred Heart Hospital1 site in 1 country50 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cesarean Section
Sponsor
Hallym University Kangnam Sacred Heart Hospital
Enrollment
50
Locations
1
Primary Endpoint
Onset time of epidural anesthesia (up to T6 level)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
January 31, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Hallym University Kangnam Sacred Heart Hospital
Responsible Party
Principal Investigator
Principal Investigator

Choi Eun MI

Professor

Hallym University Kangnam Sacred Heart Hospital

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Incidence of hypotension(During the operation)
  • Incidence of nausea and vomiting(From the time of epidural injection to 1 hour after entering recovery room)

Study Sites (1)

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