The Effect of Warm Local Anesthetic Solution on Epidural Anesthesia

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860402
• Other study ID #: kangnamANE
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2020
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Other:
• Temperature
temperature of drug

Locations

Country	Name	City	State
Korea, Republic of	Kangnam sacred heart hospital	Seoul	Yeongdeungpo-gu

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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