NCT03946982

Brief Summary

Whether low thoracic epidural analgesia improves postoperative cesarean pain qualities than conventional lumbar epidural analgesia?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

May 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

May 28, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

June 30, 2021

Status Verified

May 1, 2020

Enrollment Period

1.8 years

First QC Date

May 9, 2019

Last Update Submit

June 27, 2021

Conditions

Post-cesarean Pain Control Quality

Keywords

Patient controlled epidural analgesia ,Cesarean delivery,pain management,epidural opioid

Outcome Measures

Primary Outcomes (2)

  • Proportion of women with a visual analogue scale> 33 mm

    postoperative two days

  • Pain intensity

    pain intensities in three category, namely static, dynamic and uterine cramping, gauged by a 100 mm visual analogue scale

    postoperative two days

Secondary Outcomes (1)

  • Adverse effects

    postoperative two days

Study Arms (4)

Low thoracic patient controlled epidural analgesia

EXPERIMENTAL
Procedure: low thoracic epidural

Lumbar epidural patient controlled epidural analgesia

ACTIVE COMPARATOR
Procedure: lumbar epidural

Low thoracic epidural morphine

ACTIVE COMPARATOR
Procedure: low thoracic epidural

Lumbar epidural morphine

ACTIVE COMPARATOR
Procedure: lumbar epidural

Interventions

low thoracic epiduralPROCEDURE

obstetric epidural catheters inserted at low thoracic intervertebral spaces

Low thoracic epidural morphineLow thoracic patient controlled epidural analgesia
lumbar epiduralPROCEDURE

obstetric epidural catheters inserted at low thoracic intervertebral spaces (conventional)

Lumbar epidural morphineLumbar epidural patient controlled epidural analgesia

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age between 20-yr and 50-yr parturients
  • elective cesarean delivery

You may not qualify if:

  • contraindicated to regional anesthesia, eg. coagulopathy (INR\> 1.5; platelet\< 80000...etc)
  • significant co-morbidities, eg. preeclamspia, heart failure with New York Heart Association (NYHA) Classification\> class 2
  • allergy to opioids or local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Officials

  • Chun-Yu Wu

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 13, 2019

Study Start

May 28, 2019

Primary Completion

March 27, 2021

Study Completion

April 30, 2021

Last Updated

June 30, 2021

Record last verified: 2020-05

Locations

TW(1)