- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03381690
Preoperative Epidural Labor Analgesia and Postoperative Pain
November 21, 2019 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
222
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi
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Seongnam, Gyeonggi, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patients underwent elective or emergent Cesarean section.
Description
Inclusion Criteria:
- Cesarean section(C-sec) under spinal anesthesia
Exclusion Criteria:
- Patients without accurate medical records
- Failure of epidural analgesia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Epidural (ED) emergent C-sec
|
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).
|
|
Non-ED emergent C-sec
|
|
|
Non-ED elective C-sec
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The change of numerical rating scale for postoperative pain
Time Frame: At postoperative 6h, 24h, 48h, and 72h.
|
At postoperative 6h, 24h, 48h, and 72h.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The change of postoperative analgesic consumption
Time Frame: At postoperative 6h, 24h, 48h, and 72h.
|
At postoperative 6h, 24h, 48h, and 72h.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2017
Primary Completion (ACTUAL)
August 31, 2018
Study Completion (ACTUAL)
August 31, 2018
Study Registration Dates
First Submitted
October 24, 2017
First Submitted That Met QC Criteria
December 18, 2017
First Posted (ACTUAL)
December 22, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 22, 2019
Last Update Submitted That Met QC Criteria
November 21, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Csec postop pain
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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