MedPath

The Effect of Warm Local Anesthetic Solution on Epidural Anesthesia

Completed
Conditions
Cesarean Section
Interventions
Other: Temperature
Registration Number
NCT03860402
Lead Sponsor
Hallym University Kangnam Sacred Heart Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
50
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Pre-warmed drugTemperaturePre-warmed (38°C) ropivacaine (7.5mg/ml) 19ml and fentanyl 50ug are injected via the epidural route at the L3-4 interspace.
Primary Outcome Measures
NameTimeMethod
Onset time of epidural anesthesia (up to T6 level)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 Outcome Measures
NameTimeMethod
Incidence of hypotensionDuring the operation

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.

Incidence of nausea and vomitingFrom the time of epidural injection to 1 hour after entering recovery room

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.

Trial Locations

Locations (1)

Kangnam sacred heart hospital

🇰🇷

Seoul, Yeongdeungpo-gu, Korea, Republic of

© Copyright 2025. All Rights Reserved by MedPath