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
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
Scientific
Kobari General Hospital
29-1
Yokouchi
Noda
Chiba
278-0051
Japan
 ORCID ID |
0000-0003-4438-132X |
|---|---|
| Phone | +81-4-7124-6666 |
| oshimasayuki@gmail.com |
Study information
| Study design | Prospective non-inferiority pilot randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Posturography can detect potential impairment of standing stability due to epidural fentanyl after Cesarean delivery |
| Study objectives | 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(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) studied | 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 |
| 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 study start date | 01/01/2018 |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 16 |
| Total final enrolment | 16 |
| Key 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 |
| Key exclusion criteria | 1. ASA III or higher 2. Needs an urgent Cesarean delivery 3. Needs general anesthesia for a Cesarean delivery |
| Date of first enrolment | 01/05/2018 |
| Date of final enrolment | 30/04/2019 |
Locations
Countries of recruitment
- Japan
Study participating centre
Yokouchi
Noda
Chiba
278-0051
Japan
Sponsor information
Hospital/treatment centre
29-1
Yokouchi
Noda
Chiba
278-0051
Japan
| Phone | +81-4-7124-6666 |
|---|---|
| ikyoku-hisho@kobari.or.jp | |
| Website | http://www.kobari.or.jp |
"ROR" |
https://ror.org/04yn2he76 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication of findings in a peer-review journal. |
| IPD sharing plan | The 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.
