Cesarean SectionNCT03381690
Preoperative Epidural Labor Analgesia and Postoperative Pain
An observational study of Cesarean Section, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Parturients who undergo emergency Cesarean section (C-sec) after experiencing labor pain are likely to develop pain-induced central sensitization. The investigators hypothesized that those without epidural labor analgesia undergoing subsequent emergency C-sec would experience more severe postoperative pain or require… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Epidural labor analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 222 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2017to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent elective or emergent Cesarean section.
Who may be able to join
- Cesarean section(C-sec) under spinal anesthesia
Who cannot join
- Patients without accurate medical records
- Failure of epidural analgesia
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: The Influence of Preoperative Epidural Labor Analgesia on Postoperative Pain in Parturients Undergoing Cesarean Section: a Retrospective Analysis
Parturients who undergo emergency Cesarean section (C-sec) after experiencing labor pain are likely to develop pain-induced central sensitization. The investigators hypothesized that those without epidural labor analgesia undergoing subsequent emergency C-sec would experience more severe postoperative pain or require more analgesia after C-sec compared to those with epidural labor analgesia. Thus, the investigators conducted this retrospective study by grouping parturients undergoing emergency C-sec after experiencing labor pain into two groups (epidural labor group and no epidural labor group) and those undergoing elective C-sec aimed to compare the effect of epidural labor analgesia on postoperative pain severity and analgesic consumption.
- Conditions
- Cesarean Section
- Being tested
- Epidural labor analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural labor analgesiaProcedure or surgery
Epidural catheter was inserted for labor analgesia using an 18-gauge Tuohy needle and a 20 gauge epidural catheter. In our institute, for epidural labor analgesia, 10 ml bolus of 0.075% levobupivacaine mixed with fentanyl 2 μg/ml was administered and same regimen was continuously infused by patient-controlled epidural analgesia (infusion rate : 10 ml/hr, bolus : 4 ml, lockout time: 30 min).
| Study group | Role | What they receive |
|---|---|---|
| Epidural (ED) emergent C-sec | Not described Receives: Procedure: Epidural labor analgesia | |
| Non-ED emergent C-sec | Not described | |
| Non-ED elective C-sec | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of numerical rating scale for postoperative pain
Measured: At postoperative 6h, 24h, 48h, and 72h.
Secondary outcomes (1)
The change of postoperative analgesic consumption
Measured: At postoperative 6h, 24h, 48h, and 72h.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start1 Sep 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381690
- Sponsor's protocol ID
- Csec postop pain
- Status last verified
- Nov 2019
- First submitted
- 24 Oct 2017
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Preoperative Epidural Labor Analgesia on Postoperative Pain in Parturients Undergoing Cesarean Section: a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03381690
- Acronym / sponsor ID
- Csec postop pain
- Conditions
- Cesarean Section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parturients who undergo emergency Cesarean section (C-sec) after experiencing labor pain are likely to develop pain-induced central sensitization. The investigators hypothesized that those without epidural labor analgesia undergoing subsequent emergency C-sec would experience more severe postoperative pain or require more analgesia after C-sec compared to those with epidural labor analgesia. Thus, the investigators conducted this retrospective study by grouping parturients undergoing emergency C-sec after experiencing labor pain into two groups (epidural labor group and no epidural labor group) and those undergoing elective C-sec aimed to compare the effect of epidural labor analgesia on postoperative pain severity and analgesic consumption.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epidural (ED) emergent C-sec | – | Procedure: Epidural labor analgesia |
| Non-ED emergent C-sec | – | – |
| Non-ED elective C-sec | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent elective or emergent Cesarean section.
Key inclusion criteria (1 listed)
- Cesarean section(C-sec) under spinal anesthesia
Key exclusion criteria (2 listed)
- Patients without accurate medical records
- Failure of epidural analgesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural labor analgesiaEpidural catheter was inserted for labor analgesia using an 18-gauge Tuohy needle and a 20 gauge epidural catheter. In our institute, for epidural labor analgesia, 10 ml bolus of 0.075% levobupivacaine mixed with fentanyl 2 μg/ml was administered and same regimen was continuously infused by patient-controlled epidural analgesia (infusion rate : 10 ml/hr, bolus : 4 ml, lockout time: 30 min). | Procedure or surgery | Epidural (ED) emergent C-sec |
Primary outcome
The change of numerical rating scale for postoperative pain
Time frame: At postoperative 6h, 24h, 48h, and 72h.
1 secondary outcome
The change of postoperative analgesic consumption
Time frame: At postoperative 6h, 24h, 48h, and 72h.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of numerical rating scale for postoperative pain (time frame: At postoperative 6h, 24h, 48h, and 72h.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.