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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Analgesia
- Sponsor
- Ataturk University
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Difference between total local anaesthetic consumption
- Status
- Recruiting
- Last Updated
- 2 years ago
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.
Investigators
Aysenur Dostbil
Clinical Professor
Ataturk University
Eligibility Criteria
Inclusion Criteria
- •Healthy nulliparous women
- •American Society of Anaesthesiology Score of II
- •During active labor
- •At weeks 37-
- •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
Outcomes
Primary Outcomes
Difference between total local anaesthetic consumption
Time Frame: 5 hours or before if the labor is completed
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.