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

Study Overview
=================
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.

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

Conditions
-----------------
Post-cesarean Pain Control Quality

Intervention / Treatment
-----------------
* Procedure: low thoracic epidural
* Procedure: lumbar epidural


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low thoracic patient controlled epidural analgesia<br> | Procedure: low thoracic epidural<br>* obstetric epidural catheters inserted at low thoracic intervertebral spaces<br>|
| Active Comparator: Lumbar epidural patient controlled epidural analgesia<br> | Procedure: lumbar epidural<br>* obstetric epidural catheters inserted at low thoracic intervertebral spaces (conventional)<br>|
| Active Comparator: Low thoracic epidural morphine<br> | Procedure: low thoracic epidural<br>* obstetric epidural catheters inserted at low thoracic intervertebral spaces<br>|
| Active Comparator: Lumbar epidural morphine<br> | Procedure: lumbar epidural<br>* obstetric epidural catheters inserted at low thoracic intervertebral spaces (conventional)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects | Incidences of epidural-related adverse effects including sedation states, sensory blockade, motor blockade, pruritus, nausea and vomiting | postoperative two days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient controlled epidural analgesia ,Cesarean delivery,pain management,epidural opioid