Analgesia
Conditions
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.
Interventions
PROCEDUREGroup I: Lower Volume with Higher Anaesthetic Concentration
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
PROCEDUREGroup II: Higher Volume with LowerAnaesthetic Concentration
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
Sponsors
Ataturk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy nulliparous women 2. American Society of Anaesthesiology Score of II 3. During active labor 4. At weeks 37-42. 5. Singlet vertex presentation 6. Cervical dilation \<5 cm at the request of labor analgesia 7. VAS score \>40
Exclusion criteria
1. Age \<20 or \>45, 2. Morbid obesity 3. Presence of pregnancy-related comorbidities (e.g: gestational diebetes, gestational hypertension and preeclampsia) 4. History of drug abuse 5. Contrindication for neuraxial blocks 6. Conditions that increase the risk of need for cesarean section (e.g. placenta previa, uterus abnormalities or surgeries) 7. Diagnosed fetal abnormalities 8. Cases where dura gets punctured unintendedly with the epiduralneedle 9. Cases where flow of cerebrospinal fluid (CSF) is not observed after dural puncture 10. Cases where a cesarean section is performed at any stage of labor 11. Cases where labor is completed in 1 hour from the start of analgesia procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between total local anaesthetic consumption | 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactAyşenur Dostbil
Backup ContactAyşenur Dostbil
Outcome results
None listed