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The Effect of Warm Local Anesthetic Solution on Epidural Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03860402
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
Choi Eun MI, Hallym University Kangnam Sacred Heart Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Cesarean Section Other: Temperature

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
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effect of Warm Local Anesthetic Solution for Sensory Block on Epidural Anesthesia of Cesarean Delivery : a Randomized Controlled Study
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: Temperature
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of hypotension [ Time Frame: During 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.

  2. Incidence of nausea and vomiting [ Time Frame: From 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860402


Locations
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Korea, Republic of
Kangnam sacred heart hospital
Seoul, Yeongdeungpo-gu, Korea, Republic of, KS013
Sponsors and Collaborators
Hallym University Kangnam Sacred Heart Hospital
Investigators
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Principal Investigator: Eun Mi Choi, MD Hallym University Kangnam Sacred Heart Hospital
More Information
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Responsible Party: Choi Eun MI, Professor, Hallym University Kangnam Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT03860402    
Other Study ID Numbers: kangnamANE
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Choi Eun MI, Hallym University Kangnam Sacred Heart Hospital:
pre-warmed epiural anesthetics
epidural anesthesia