Condition category
Pregnancy and Childbirth
Date applied
29/03/2020
Date assigned
31/03/2020
Last edited
31/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Early mobilization after Cesarean delivery is encouraged to decrease blood clots (thromboembolic events) and shorten the length of hospital stay. Although postoperative pain management with epidural pain medication can perfectly fit the purpose, it might impair the capability of standing and walking due to epidural local anesthetics and opioids. The purpose of this study was to determine the safety and efficacy of different doses in epidural fentanyl in addition to local anesthetics while ambulation of those who had an elective Cesarean delivery.

Who can participate?
Any term pregnant woman with ASA I or II who undergoes an elective Cesarean delivery and receives an epidural catheter at T12/L1 following spinal anesthesia.

What does the study involve?
Participants will be randomly allocated to receive continuous epidural infusion of 0.2% ropivacaine containing either 2.5 mcg/ml (Group 1) or 5 mcg/ml fentanyl (Group 2) started at the rate of 5 ml/h after Cesarean delivery.

What are the possible benefits and risks of participating?
Possible benefits are encouragement of early mobilization after Cesarean delivery. Possible risks are falling during ambulation.

Where is the study run from?
Kobari General Hospital (Japan)

When is the study starting and how long is it expected to run for?
May 2018 to December 2019

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Masayuki Oshima, oshimasayuki@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Masayuki Oshima

ORCID ID

https://orcid.org/0000-0003-4438-132X

Contact details

Kobari General Hospital
29-1
Yokouchi
Noda
Chiba
278-0051
Japan
+81-4-7124-6666
oshimasayuki@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Posturography can detect potential impairment of standing stability due to epidural fentanyl after Cesarean delivery

Acronym

Study hypothesis

The objective of the current study is to compare standing stability measured by posturography between two different concentrations of epidural fentanyl in addition to local anesthetics in post-Cesarean delivery women with continuous epidural analgesia.

Ethics approval

Approved 26/04/2018, Local ethics committee of Kobari General Hospital (29-1, Yokouchi, Noda, Chiba, 278-0051, Japan; no tel. provided; ikyoku-hisho@kobari.or.jp), ref: 34-2018

Study design

Prospective non-inferiority pilot randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Spinal anesthesia during an elective Cesarean delivery

Intervention

Continuous epidural infusion of 0.2% ropivacaine containing either 2.5 mcg/ml (Group 1) or 5 mcg/ml fentanyl (Group 2) is randomly assigned to an individual and started at the rate of 5 ml/h postoperatively.
Total duration of treatment (i.e., continuous epidural analgesia) was 48 hours after their Cesarean delivery. And the total duration of follow-up was up to 7 days after their Cesarean delivery. Participants were randomized into 2 groups by a table of random numbers.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Sway area measured by a posturography at baseline, one and seven days after Cesarean delivery

Secondary outcome measures

1. Pain status with Visual Analogue Scale once a day after Cesarean delivery up to post-operative seven days
2. Motor function of legs with Bromage scale on post-operative day one

Overall trial start date

01/01/2018

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Term pregnant woman with ASA I or II
2. Elective Cesarean delivery
3. Received an epidural catheter at T12/L1 following spinal anesthesia

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

16

Participant exclusion criteria

1. ASA III or higher
2. Needs an urgent Cesarean delivery
3. Needs general anesthesia for a Cesarean delivery

Recruitment start date

01/05/2018

Recruitment end date

30/04/2019

Locations

Countries of recruitment

Japan

Trial participating centre

Kobari General Hospital
29-1 Yokouchi Noda
Chiba
278-0051
Japan

Sponsor information

Organisation

Kobari General Hospital

Sponsor details

29-1
Yokouchi
Noda
Chiba
278-0051
Japan
+81-4-7124-6666
ikyoku-hisho@kobari.or.jp

Sponsor type

Hospital/treatment centre

Website

http://www.kobari.or.jp

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication of findings in a peer-review journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date

01/06/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

31/03/2020: Trial’s existence confirmed by Local ethics committee of Kobari General Hospital.