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Comparisons Between Low Thoracic and Lumbar Epidural Analgesia on Postoperative Pain Low Thoracic v.s. Lumbar Epidural for Post-cesarean Pain

Primary Purpose

Post-cesarean Pain Control Quality

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

low thoracic epidural

lumbar epidural

About this trial

This is an interventional treatment trial for Post-cesarean Pain Control Quality focused on measuring Patient controlled epidural analgesia ,Cesarean delivery,pain management,epidural opioid

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion:

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

Exclusion:

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

Sites / Locations

National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Low thoracic patient controlled epidural analgesia

Lumbar epidural patient controlled epidural analgesia

Low thoracic epidural morphine

Lumbar epidural morphine

Arm Description

Outcomes

Primary Outcome Measures

Proportion of women with a visual analogue scale> 33 mm

Pain intensity

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

Secondary Outcome Measures

Adverse effects

Incidences of epidural-related adverse effects including sedation states, sensory blockade, motor blockade, pruritus, nausea and vomiting

Full Information

NCT ID

NCT03946982

First Posted

May 9, 2019

Last Updated

June 27, 2021

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03946982

Brief Title

Comparisons Between Low Thoracic and Lumbar Epidural Analgesia on Postoperative Pain Low Thoracic v.s. Lumbar Epidural for Post-cesarean Pain

Official Title

Comparisons Between Low Thoracic and Lumbar Epidural Analgesia on Postoperative Pain Management Qualities After Cesarean Delivery: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

May 28, 2019 (Actual)

Primary Completion Date

March 27, 2021 (Actual)

Study Completion Date

April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

Postoperative pain remains the leading cause of concern in women faced with undergoing a cesarean delivery. Inadequate acute pain management is associated with numerous negative effects, including delayed postpartum recovery, interference with mother-child bonding because postoperative pain limits breastfeeding, and a high risk of postpartum depression and persistent pain. Epidural analgesia (EA) is being increasingly preferred to systemic opioid because of better analgesic effect. Although EA is widely used for cesarean delivery, the effect of the site of epidural catheter insertion on the quality of postoperative pain management remains inadequately investigated. For example, placement of the epidural catheter in the low thoracic intervertebral spaces may be more suitable for catheter-incision-congruent analgesia during caesarean delivery than in the lumbar intervertebral space; however, epidural catheter insertion is conventionally recommended at the lumbar intervertebral space. Therefore, in this study, we aim to investigate the difference in post-cesarean pain control quality between low thoracic EA and lumbar EA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-cesarean Pain Control Quality

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

189 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low thoracic patient controlled epidural analgesia

Arm Type

Experimental

Arm Title

Lumbar epidural patient controlled epidural analgesia

Arm Type

Active Comparator

Arm Title

Low thoracic epidural morphine

Arm Type

Active Comparator

Arm Title

Lumbar epidural morphine

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

low thoracic epidural

Intervention Description

obstetric epidural catheters inserted at low thoracic intervertebral spaces

Intervention Type

Procedure

Intervention Name(s)

lumbar epidural

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of women with a visual analogue scale> 33 mm

Time Frame

postoperative two days

Title

Pain intensity

Description

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

Time Frame

postoperative two days

Secondary Outcome Measure Information:

Title

Adverse effects

Description

Incidences of epidural-related adverse effects including sedation states, sensory blockade, motor blockade, pruritus, nausea and vomiting

Time Frame

postoperative two days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion: age between 20-yr and 50-yr parturients elective cesarean delivery Exclusion: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chun-Yu Wu

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

Comparisons Between Low Thoracic and Lumbar Epidural Analgesia on Postoperative Pain Low Thoracic v.s. Lumbar Epidural for Post-cesarean Pain

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