None listed
Conditions
Brief summary
Childbirth may cause the most severe pain some women experience during their lifetime. Epidural analgesia (EA) has been established as the most effective tool in relieving labor pain and is deemed as the golden standard in obstetric anesthesia. There are ongoing efforts aiming at refinement of labor EA contributing to maternal satisfaction. Following this, new techniques have been introduced in clinical practice. One of them, relatively new, is dural puncture epidural (DPE). The primary aim of this study was to test the hypothesis that DPE provides faster onset of EA and lessens the incidence of breakthrough pain assessed by numeric rating scale (NRS). The number of additional drug boluses given along continuous infusion of epidural local anesthetic mixture was recorded and compared among groups. We assumed that DPE group would have decreased incidence of breakthrough pain and fewer overall administration of additional boluses during labor. As secondary aim, we compared the time that had elapsed from first bolus until delivery, as well as the incidence of instrumented vaginal delivery and emergent cesarean section among groups due to possibly marked motor deficit assessed by Bromage scale. We hypothesized that DPE would not affect course of labor.
Interventions
Lumbar epidural puncture was performed with an 18-gauge Tuohy needle, at the level between third and fourth or fourth and fifth lumbar vertebra. Patient was positioned in sitting position for the procedure. Epidural space was identified by using loss of resistance technique with syringe containing 10 ml of saline. Afterwards, atraumatic Whitacre needle, 27-gauge, 12 mm of length was inserted through epidural needle until free flow of cerebrospinal fluid (CSF) was obtained. The spinal needle was
Lumbar epidural puncture was performed with an 18-gauge Tuohy needle, at the level between third and fourth or fourth and fifth lumbar vertebra. Patient was positioned in sitting position for the procedure. Epidural space was identified by using loss of resistance technique with syringe containing 10 ml of saline. Afterwards, atraumatic Whitacre needle, 27-gauge, 12 mm of length was inserted through epidural needle until free flow of cerebrospinal fluid (CSF) was obtained. The spinal needle was then withdrawn without administration of any medication intrathecally. Epidural catheter (19 gauge) was inserted 5-6 cm into epidural space. Administration of test dose, containing of 3 ml of 2% lidocaine was preceded by negative aspiration of blood or CSF. After the test dose came negative, epidural analgesia was initiated with a 10 ml bolus of 0,125% bupivacaine administered over 5 minutes. As analgetic adjuvants we used fentanyl 1,5 mcg/ml according to local institutional protocol. Upon completion of epidural bolus and attainment of adequate analgesia, continuous epidural infusion of 0,08% bubivacaine mixed with fentanyl 1.5 mcg/ml was started at 8 ml per hour. In case of inadequate epidural analgesia (defined as NRS>3) additional boluses of local anesthetic mixture (0.125% bupivacaine and fentany 1.5 mcg per ml, overall volume of single bolus is 10 ml) wil be administered via epidural catheter. Overall volume of drugs administered via epidural catheter should not exceed 25 ml during an hour. Epidural catheter placement and administration of drug via epidural catheter was performed by anesthesiologist in hospital delivery room. After completion of third stage of labour, epidural catheter will be removed. Adequacy of epidural analgesia and neurological assessment of parturients will be recorded in one hour intervals.
Sponsors
Iva Pažur
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Healthy nulliparous parturients at 38 to 42 weeks of gestation, requesting epidural analgesia. Patients who met enrollment criteria were aged 18 years or more in active labor with cervical dilatation less than 6 cm at the moment of epidural insertion.
Exclusion criteria
Preeclampsia, eclampsia, contraindications for neuroaxial anesthesia (coagulopathies, infection at puncture site, aortic valve stenosis, central nervous system disorders)
Outcome results
None listed