The Effect of Warm Local Anesthetic Solution on Epidural Anesthesia

NCT03860402 | Completed

• 1 other identifier: kangnamANE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section

Keywords

pre-warmed epiural anesthetics; epidural anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (2)

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

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.

Interventions

Temperature OTHER

temperature of drug

Pre-warmed drug

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Among the pregnant women who were administered cesarean section in this study, those who agreed to participate in this study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hallym University Kangnam Sacred Heart Hospital: lead

Study Sites (1)

Kangnam sacred heart hospital

Seoul, Yeongdeungpo-gu, KS013, South Korea

Location

MeSH Terms

Interventions

Temperature

Intervention Hierarchy (Ancestors)

Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment, Controlled; Environment and Public Health

Study Officials

• Eun Mi Choi, MD

  Hallym University Kangnam Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: March 1, 2019
• Study Start: February 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)