NCT03381690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

12 months

First QC Date

October 24, 2017

Last Update Submit

November 21, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The change of numerical rating scale for postoperative pain

    At postoperative 6h, 24h, 48h, and 72h.

Secondary Outcomes (1)

  • The change of postoperative analgesic consumption

    At postoperative 6h, 24h, 48h, and 72h.

Study Arms (3)

Epidural (ED) emergent C-sec

Procedure: Epidural labor analgesia

Non-ED emergent C-sec

Non-ED elective C-sec

Interventions

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).

Epidural (ED) emergent C-sec

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients underwent elective or emergent Cesarean section.

You may qualify if:

  • Cesarean section(C-sec) under spinal anesthesia

You may not qualify if:

  • Patients without accurate medical records
  • Failure of epidural analgesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

October 24, 2017

First Posted

December 22, 2017

Study Start

September 1, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations