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
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