Efficacy and Safety of Electric Stimulation-guided Epidural Anesthesia for Cesarean Section
A Comparative Study of Success Rate, Efficacy, Safety Between Electric Stimulation-guided Epidural Catheter Placement and the Loss of Resistance Conventional Method for Cesarean Section
1 other identifier
interventional
40
1 country
1
Brief Summary
Forty pregnant women (36 to 41 weeks gestation) will randomly allocate to two groups. Groups will be defined based on the method used to identify the epidural space for epidural anesthesia: the loss of resistance group (n=20) and the epidural electric stimulation group (n=20). Pain during the cesarean section will be assessed using a numerical visual analog scale and maternal satisfaction by a post-partum interview. The success rate of epidural anesthesia, maternal satisfaction, and neonatal Apgar scores will be compared between groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2015
CompletedFirst Submitted
Initial submission to the registry
January 30, 2018
CompletedFirst Posted
Study publicly available on registry
February 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedFebruary 23, 2018
February 1, 2018
4 years
January 30, 2018
February 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Success rate of epidural anesthesia
Evaluation parameter : Accuracy comparison between loss of resistance and epidural electrical stimulation
Up to 6 months
Secondary Outcomes (5)
Maternal satisfaction
Up to 6 months
Neonatal Apgar score
Up to 6 months
Procedure-related complications
Up to 6 months
Minimum electrical current to elicit a response in the epidural electrical stimulation group
Up to 6 months
Additional time for epidural electrical stimulation
Up to 6 months
Study Arms (2)
Epidural electrical stimulation (EES)
EXPERIMENTALn=20
Loss of resistance (LOR)
ACTIVE COMPARATORn=20
Interventions
Using loss of resistance technique and electrical stimulation
Eligibility Criteria
You may qualify if:
- Patients who were at 36 to 41 weeks' gestation and admitted in labor to the university clinic for cesarean section were included. Patients were American Society of Anesthesiologists (ASA) physical status of I or II, and were scheduled to receive epidural anesthesia.
You may not qualify if:
- Skin infection at the injection site
- Difficult catheter placement owing to previous lumbar spinal surgery or deformity
- Presence of a hemostatic disorder or use of antiplatelet therapy
- Presence of a cardiac pacemaker.
- Removal of patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korea University Guro Hospitallead
- Sewoon Medical Co., Ltdcollaborator
Study Sites (1)
Korea University Guro Hospital
Seoul, 08308, South Korea
Related Publications (7)
Silva M, Halpern SH. Epidural analgesia for labor: Current techniques. Local Reg Anesth. 2010;3:143-53. doi: 10.2147/LRA.S10237. Epub 2010 Dec 8.
PMID: 23144567BACKGROUNDWantman A, Hancox N, Howell PR. Techniques for identifying the epidural space: a survey of practice amongst anaesthetists in the UK. Anaesthesia. 2006 Apr;61(4):370-5. doi: 10.1111/j.1365-2044.2006.04534.x.
PMID: 16548958BACKGROUNDEappen S, Blinn A, Segal S. Incidence of epidural catheter replacement in parturients: a retrospective chart review. Int J Obstet Anesth. 1998 Oct;7(4):220-5. doi: 10.1016/s0959-289x(98)80042-3.
PMID: 15321183BACKGROUNDHermanides J, Hollmann MW, Stevens MF, Lirk P. Failed epidural: causes and management. Br J Anaesth. 2012 Aug;109(2):144-54. doi: 10.1093/bja/aes214. Epub 2012 Jun 26.
PMID: 22735301BACKGROUNDTsui BC, Tarkkila P, Gupta S, Kearney R. Confirmation of caudal needle placement using nerve stimulation. Anesthesiology. 1999 Aug;91(2):374-8. doi: 10.1097/00000542-199908000-00010.
PMID: 10443599BACKGROUNDTsui BC, Gupta S, Finucane B. Confirmation of epidural catheter placement using nerve stimulation. Can J Anaesth. 1998 Jul;45(7):640-4. doi: 10.1007/BF03012093.
PMID: 9717595BACKGROUNDKim YS, Kim HS, Jeong H, Lee CH, Lee MK, Choi SS. Efficacy of electrical stimulation on epidural anesthesia for cesarean section: a randomized controlled trial. BMC Anesthesiol. 2020 Jun 10;20(1):146. doi: 10.1186/s12871-020-01063-1.
PMID: 32522156DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Sang Sik Choi, MD, PhD
Korea University Guro Hiospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- No Masking
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 30, 2018
First Posted
February 23, 2018
Study Start
March 11, 2015
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
February 23, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share