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
Sponsored by
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
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
Active Comparator
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
No
Studies a U.S. FDA-regulated Device Product
No
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
No
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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