NCT03161717

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 electrical stimulation group (n=20). Pain will be assessed using a numerical visual analog scale and maternal satisfaction by a post-partum interview. The success rate of epidural analgesia, maternal satisfaction, and neonatal Apgar scores will be compared between groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

May 22, 2017

Status Verified

May 1, 2017

Enrollment Period

4 years

First QC Date

May 18, 2017

Last Update Submit

May 18, 2017

Conditions

Epidural Analgesia

Keywords

electrical stimulationvaginal delivery

Outcome Measures

Primary Outcomes (1)

  • Success rate of epidural analgesia

    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)

EXPERIMENTAL

n=20

Device: Epidural electrical stimulation (EES)

Loss of resistance (LOR)

ACTIVE COMPARATOR

n=20

Device: Loss of resistance (LOR)

Interventions

Epidural electrical stimulation (EES)DEVICE

Using loss of resistance technique and electrical stimulation

Epidural electrical stimulation (EES)
Loss of resistance (LOR)DEVICE

Using loss of resistance technique only

Loss of resistance (LOR)

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMaternal
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were at 36 to 41 weeks' gestation and admitted in labor to the university clinic for vaginal delivery were included. Patients were American Society of Anesthesiologists (ASA) physical status of I or II, and were scheduled to receive epidural analgesia

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
  • Injection of an analgesic within the previous 12 hours
  • Presence of a cardiac pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

Related Publications (6)

  • 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: 23144567BACKGROUND

  • Wantman 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: 16548958BACKGROUND

  • Eappen 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: 15321183BACKGROUND

  • Hermanides 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: 22735301BACKGROUND

  • Tsui 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: 10443599BACKGROUND

  • Tsui 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: 9717595BACKGROUND

Study Officials

  • Sang Sik Choi, MD, PhD

    Korea University Guro Hiospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chung Hun Lee, MD

CONTACT

82-2-2626-3240bodlch@naver.com

Sang Sik Choi, MD, PhD

CONTACT

82-2-2626-3238clonidine@empal.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No Masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2017

First Posted

May 22, 2017

Study Start

March 11, 2015

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

May 22, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)