The Effect of Warm Local Anesthetic Solution on Epidural Anesthesia

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

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 Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yeongdeungpo-gu
    • Seoul, Yeongdeungpo-gu, Korea, Republic of, KS013
      • KangNam Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset time of epidural anesthesia (up to T6 level)	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.	During the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypotension	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.	During the operation
Incidence of nausea and vomiting	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.	From the time of epidural injection to 1 hour after entering recovery room

Collaborators and Investigators

• Sponsor: Hallym University Kangnam Sacred Heart Hospital
• Investigators: Principal Investigator: Eun Mi Choi, MD, Hallym University Kangnam Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): January 31, 2020

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (ACTUAL): March 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: epidural anesthesia; pre-warmed epiural anesthetics
• Other Study ID Numbers: kangnamANE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No