Standing stability among women with epidural pain relief after Cesarean delivery

ISRCTN ISRCTN14517337
DOI https://doi.org/10.1186/ISRCTN14517337
Submission date
29/03/2020
Registration date
31/03/2020
Last edited
23/07/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Masayuki Oshima
Scientific

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

ORCiD logoORCID ID 0000-0003-4438-132X
Phone +81-4-7124-6666
Email oshimasayuki@gmail.com

Study information

Study designProspective non-inferiority pilot randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titlePosturography can detect potential impairment of standing stability due to epidural fentanyl after Cesarean delivery
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedSpinal anesthesia during an elective Cesarean delivery
InterventionContinuous 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 typeProcedure/Surgery
Primary outcome measureSway area measured by a posturography at baseline, one and seven days after Cesarean delivery
Secondary outcome measures1. 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 study start date01/01/2018
Completion date31/12/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants16
Total final enrolment16
Key inclusion criteria1. Term pregnant woman with ASA I or II
2. Elective Cesarean delivery
3. Received an epidural catheter at T12/L1 following spinal anesthesia
Key exclusion criteria1. ASA III or higher
2. Needs an urgent Cesarean delivery
3. Needs general anesthesia for a Cesarean delivery
Date of first enrolment01/05/2018
Date of final enrolment30/04/2019

Locations

Countries of recruitment

  • Japan

Study participating centre

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

Sponsor information

Kobari General Hospital
Hospital/treatment centre

29-1
Yokouchi
Noda
Chiba
278-0051
Japan

Phone +81-4-7124-6666
Email ikyoku-hisho@kobari.or.jp
Website http://www.kobari.or.jp
ROR logo "ROR" https://ror.org/04yn2he76

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/06/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPublication of findings in a peer-review journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 19/07/2021 23/07/2021 Yes No

Editorial Notes

23/07/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
31/03/2020: Trial’s existence confirmed by Local ethics committee of Kobari General Hospital.