Post-cesarean Pain Control QualityNCT03946982
Comparisons Between Low Thoracic and Lumbar Epidural Analgesia on Postoperative Pain Low Thoracic v.s. Lumbar Epidural for Post-cesarean Pain
A study testing low thoracic epidural and lumbar epidural in people with Post-cesarean Pain Control Quality, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Whether low thoracic epidural analgesia improves postoperative cesarean pain qualities than conventional lumbar epidural analgesia? Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Post-cesarean Pain Control Quality
- What is being tested?
- low thoracic epidural and lumbar epidural
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 May 2019to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age between 20-yr and 50-yr parturients
- elective cesarean delivery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparisons Between Low Thoracic and Lumbar Epidural Analgesia on Postoperative Pain Management Qualities After Cesarean Delivery: a Randomized Controlled Trial
Whether low thoracic epidural analgesia improves postoperative cesarean pain qualities than conventional lumbar epidural analgesia?
Read the 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.
- Conditions
- Post-cesarean Pain Control Quality
- Being tested
- low thoracic epidural, lumbar epidural
- Keywords
- Patient controlled epidural analgesia ,Cesarean delivery,pain management,epidural opioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low thoracic epiduralProcedure or surgery
obstetric epidural catheters inserted at low thoracic intervertebral spaces
lumbar epiduralProcedure or surgery
obstetric epidural catheters inserted at low thoracic intervertebral spaces (conventional)
| Study group | Role | What they receive |
|---|---|---|
| Low thoracic patient controlled epidural analgesia | Experimental | Not described Receives: Procedure: low thoracic epidural |
| Lumbar epidural patient controlled epidural analgesia | Active comparator | Not described Receives: Procedure: lumbar epidural |
| Low thoracic epidural morphine | Active comparator | Not described Receives: Procedure: low thoracic epidural |
| Lumbar epidural morphine | Active comparator | Not described Receives: Procedure: lumbar epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women with a visual analogue scale> 33 mm
Measured: postoperative two days
Pain intensity
pain intensities in three category, namely static, dynamic and uterine cramping, gauged by a 100 mm visual analogue scale
Measured: postoperative two days
Secondary outcomes (1)
Adverse effects
Incidences of epidural-related adverse effects including sedation states, sensory blockade, motor blockade, pruritus, nausea and vomiting
Measured: postoperative two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start28 May 2019
- Primary completion27 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-cesarean Pain Control QualityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yu Wu, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946982
- Sponsor's protocol ID
- 201902009RINC
- Status last verified
- May 2020
- First submitted
- 9 May 2019
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons Between Low Thoracic and Lumbar Epidural Analgesia on Postoperative Pain Management Qualities After Cesarean Delivery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03946982
- Acronym / sponsor ID
- 201902009RINC
- Conditions
- Post-cesarean Pain Control Quality
- Keywords
- Patient controlled epidural analgesia ,Cesarean delivery,pain management,epidural opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- 27 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age between 20-yr and 50-yr parturients
- elective cesarean delivery
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low thoracic epiduralobstetric epidural catheters inserted at low thoracic intervertebral spaces | Procedure or surgery | Low thoracic epidural morphine, Low thoracic patient controlled epidural analgesia |
| lumbar epiduralobstetric epidural catheters inserted at low thoracic intervertebral spaces (conventional) | Procedure or surgery | Lumbar epidural morphine, Lumbar epidural patient controlled epidural analgesia |
Primary outcome
Proportion of women with a visual analogue scale> 33 mm
Time frame: postoperative two days
Pain intensity
Time frame: postoperative two days
pain intensities in three category, namely static, dynamic and uterine cramping, gauged by a 100 mm visual analogue scale
1 secondary outcome
Adverse effects
Time frame: postoperative two days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
Related trials for Post-cesarean Pain Control Quality
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Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
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Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial
Pain, Postoperative Pain
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MAG-PAIN - MAGnesium for Postoperative Analgesia In the Newly Delivered
Postoperative Pain, Quality of Recovery (QoR-15)
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Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery
Obstetric Pain
Recruiting
ESPB vs Intrathecal Morphine for Assessements of Quality of Recovery After Cesarean Section
Cesarean Section, Post Operative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Yu Wu principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low thoracic epidural and lumbar epidural in people with Post-cesarean Pain Control Quality, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women with a visual analogue scale> 33 mm (time frame: postoperative two days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.