Preoperative Epidural Labor Analgesia and Postoperative Pain | NCT03381690

Studies
Preoperative Epidural Labor Analgesia and Postoperative Pain

NCT03381690

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Nov 22, 2019Actual

Enrollment

222Actual

Phase

Not provided

Conditions

Cesarean Section

Interventions

Epidural labor analgesia

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Aug 31, 2018Actual

Completion Date

Aug 31, 2018Actual

First Submitted Date

Oct 24, 2017

First Submission Date that Met QC Criteria

Dec 18, 2017

First Posted Date

Dec 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2019

Last Update Posted Date

Nov 22, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyo-Seok Na, Principle investigator, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

222Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epidural (ED) emergent C-sec			Procedure: Epidural labor analgesia
Non-ED emergent C-sec
Non-ED elective C-sec

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Epidural labor analgesia	Procedure	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change of numerical rating scale for postoperative pain		At postoperative 6h, 24h, 48h, and 72h.

Secondary Outcomes

Measure	Description	Time Frame
The change of postoperative analgesic consumption		At postoperative 6h, 24h, 48h, and 72h.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cesarean section(C-sec) under spinal anesthesia

Exclusion Criteria:

Patients without accurate medical records
Failure of epidural analgesia

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients underwent elective or emergent Cesarean section.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463-707	South Korea