Effect of Higher Volume and Lower Dose on Analgesic Quality During Labor Analgesia With Dural Puncture Epidural

Study Overview
=================
Brief Summary
-----------------
It is aimed in this study to compare the effect of using local anaesthetics in a higher volume and lower dose on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique.

Detailed Description
-----------------
This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 20 to 45 with American Society of Anesthesiologists (ASA) II classification, full-term, nulliparous and singleton pregnancies. Using a randomisation procedure, the participants will be allocated into two equal groups: Group I and Group II.

Official Title
-----------------
The Effect of Using Local Anesthetics in a Higher Volume and Lower Dose On Analgesic Quality of Labor Analgesia With Dural Puncture Epidural Technique: Double-Blind Randomised Controlled Study

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Procedure: Group I: Lower Volume with Higher Anaesthetic Concentration
* Procedure: Group II: Higher Volume with LowerAnaesthetic Concentration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy nulliparous women American Society of Anaesthesiology Score of II During active labor At weeks 37-42. Singlet vertex presentation Cervical dilation <5 cm at the request of labor analgesia VAS score >40 Exclusion Criteria: Age <20 or >45, Morbid obesity Presence of pregnancy-related comorbidities (e.g: gestational diebetes, gestational hypertension and preeclampsia) History of drug abuse Contrindication for neuraxial blocks Conditions that increase the risk of need for cesarean section (e.g. placenta previa, uterus abnormalities or surgeries) Diagnosed fetal abnormalities Cases where dura gets punctured unintendedly with the epiduralneedle Cases where flow of cerebrospinal fluid (CSF) is not observed after dural puncture Cases where a cesarean section is performed at any stage of labor Cases where labor is completed in 1 hour from the start of analgesia procedure.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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 I<br>The patients will be given 10 ml of a solution containing 0,1% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether. Level of sensory block will be tested by testing with ice from S2 dermatome cephally. Analgesia will be maintained by programmed intermittant epidural (PIE) boluses of 7,5 ml of the same solution once in every hour, starting 1 hour after the loading dose. In addition, patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered. Breakthrough pain that requires even further analgesia will be treated with an epidural bolus of 5 ml of 0,125% bupivacain solution. | Procedure: Group I: Lower Volume with Higher Anaesthetic Concentration<br>* 10 ml of a solution containing 0,1% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether, maintained by programmed intermittant epidural (PIE) boluses of 7,5 ml of the same solution once in every hour, starting 1 hour after the loading dose. patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered<br>|
| Active Comparator: Group II<br>The patients will be given 20 ml of a solution containing 0,0625% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether. Analgesia will be maintained by programmed intermittant epidural boluses of 15 ml of the same solution once in every hour, starting 1 hour after the loading dose. In addition, patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered. Breakthrough pain that requires even further analgesia will be treated with an epidural bolus of 5 ml of 0,125% bupivacain solution. | Procedure: Group II: Higher Volume with LowerAnaesthetic Concentration<br>* 20 ml of a solution containing 0,0625% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether, maintained by programmed intermittant epidural boluses of 15 ml of the same solution once in every hour, starting 1 hour after the loading dose. patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between total local anaesthetic consumption | The study will involve monitoring the patients starting 2 minutes after the initial epidural dose, every 2 minutes during the first 20 minutes. Monitoring will continue at the 30th minute, and once in every 90 minutes for 5 hours or until labor is completed. Total bupivacain consumption will be calculated as follows: PIEB + PCEA + boluses by the clinician. Bupivacain consumption per hour will be calculated. | 5 hours or before if the labor is completed |