Different Epidural Initiation Volumes

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the effect of different epidural initiation volumes on postoperative pain scores, local anesthetic requirements, and motor block in patients who undergo patient controlled epidural analgesia for postoperative pain after cesarean section.

Detailed Description
-----------------
90 minutes after combined epidural spinal catheter insertion, three different volumes (5 mL, 10 mL, and 20 mL) are administered with a patient-controlled epidural analgesia (PCEA) device through the epidural catheter. For each group, 0.625% bupivacain + 2 μg/mL fentanyl, is administered. The visual analog scale, first analgesic demand time, the number of PCEA requirement per hour, morphine requirement, nausea-vomiting, itching, motor block, hypotension, and total consumed analgesic, and ephedrine amounts of the patients are recorded in the recovery room and at postoperative 2, 4, 6, 12 hours.

Official Title
-----------------
Effects of Different Epidural Initiation Volumes on Postoperative Analgesia in Cesarean Delivery

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: 5 mL epidural initiation volume (bupivacaine + fentanyl)
* Drug: 10 mL epidural initiation volume (bupivacaine + fentanyl)
* Drug: 20 mL epidural initiation volume (bupivacaine + fentanyl)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiology risks classification II Term pregnant Exclusion Criteria: Multiple pregnancy Diabetes mellitus Hypertension Coagulopathy Severe cardiac, neurological and pulmonary disease Allergy to the study drugs Difficulty in understanding the use of the patient controlled analgesia device

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 5<br>5 mL epidural initiation volume (bupivacaine + fentanyl) | Drug: 5 mL epidural initiation volume (bupivacaine + fentanyl)<br>* 5 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter<br>* Other names: Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL);|
| Active Comparator: Group 10<br>10 mL epidural initiation volume (bupivacaine + fentanyl) | Drug: 10 mL epidural initiation volume (bupivacaine + fentanyl)<br>* 10 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter<br>* Other names: Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL);|
| Active Comparator: Group 20<br>20 mL epidural initiation volume (bupivacaine + fentanyl) | Drug: 20 mL epidural initiation volume (bupivacaine + fentanyl)<br>* 20 mL 0.625% bupivacaine + + 2 μg/mL fentanyl solution is administered from epidural catheter<br>* Other names: Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postoperative pain scores | Visual analog scale | up to 12 hours after cesarean delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First analgesic demand time | Time to first analgesic requirement (first patient controlled epidural analgesic demand time) | up to 12 hours after cesarean delivery | 
| The number of analgesic requirement | The number of patient controlled epidural analgesic requirement per hour | up to 12 hours after cesarean delivery | 
| Morphine requirement | Intravenous morphine administration | up to 12 hours after cesarean delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cesarean section, combined spinal epidural anesthesia, patient controlled epidural analgesia, postoperative pain