None listed
Conditions
Brief summary
The goal of the study is to find the optimal, in terms of efficacy and safety, concentration of local anesthetic for Patient-controlled epidural labour pain analgesia. Our hypothesis is that the optimal concentration of local anesthetics for labour pain analgesia should be 0.1%, because we think that the concentration of 0.125% may cause a bigger motor block and lower patient satisfaction, and the pain reducing effect of concentration of 0.0625 % wold not always be satisfactory. In order to assess the optimal concentration of local anesthetic we use the same drug concentration for initial epidural bolus and later for Patient-controlled epidural analgesia. The strict inclusion and exclusion criteria are chosen in order to purify the contingent. We also include only primiparas because the course of labour and the pattern of pain is different for primiparas and for multiparas.
Interventions
Intervention: patient controlled epidural analgesia
Mode of administration: Initial dose 10 ml; after 15 minutes from initial dose start of the background infusion 10 ml/h, bolus dose 2 ml, lockout interval 15 min.
If necessary additional 5 ml bolus, by anesthesiologist.
The same combination of drugs (one of the possible arms) is used in all steps of analgesia for the same patient.
Duration: until baby delivery
Drugs: opioid (fentanyl 2mcg/ml) and local anesthetic (bupivacaine or levobupivacai
Intervention: patient controlled epidural analgesia Mode of administration: Initial dose 10 ml; after 15 minutes from initial dose start of the background infusion 10 ml/h, bolus dose 2 ml, lockout interval 15 min. If necessary additional 5 ml bolus, by anesthesiologist. The same combination of drugs (one of the possible arms) is used in all steps of analgesia for the same patient. Duration: until baby delivery Drugs: opioid (fentanyl 2mcg/ml) and local anesthetic (bupivacaine or levobupivacaine) Possible concentrations of local anesthetic: 0.0625% (0.625 mg/ml), 0.1% (1 mg/ml), 0.125% (1.25 mg/ml) Intervention arms are six: Arm 1 - bupivacaine 0.0625% (0.625 mg/ml)+fentanyl 2mcg/ml. Arm 2 - levobupivacaine 0.0625% (0.625 mg/ml)+fentanyl 2mcg/ml Arm 3 - bupivacaine 0.1% (1 mg/ml)+fentanyl 2mcg/ml Arm 4 - levobupivacaine 0.1% (1 mg/ml)+fentanyl 2mcg/ml Arm 5 - bupivacaine 0.125% (1.25 mg/ml)+ fentanyl 2mcg/ml Arm 6 - levobupivacaine 0.125% (1.25 mg/ml)+fentanyl 2mcg/ml Initial dose is infused directly through epidural catheter; then the patient controlled epidural analgesia device is connected and all drugs are infused using it.
Sponsors
Kestutis Rimaitis
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Primiparas, gestational age >37 and <41 weeks, who had requested for epidural analgesia during labor, cervical dilatation <5 cm, the beginning of labor is spontaneous. American Society of Anaesthesiologists (ASA) physical status 1 or 2; Uncomplicated, vertex-presenting, singleton pregnancy.
Exclusion criteria
Arterial hypertension, preeclampsia, eclampsia. Diabetes mellitus (gestational, type 1 and type 2). There are contraindications for epidural analgesia due to haemodynamic, infectious, allergic, neurological or hematological reasons. Multiple pregnancy, multiparity, induced labour Body Mass Index >40 kg/m2, height less than 150 cm. Fetal growth restrictions or other fetal abnormalities.
Outcome results
None listed