Labor Pain
Conditions
Keywords
epidural analgesia, patient controlled analgesia, obstetric outcome
Brief summary
The study aims to determine whether the use of automated intermittent devices for labor analgesia could prevent the increase of instrumental deliveries, with same analgesia. Moreover it will evaluate if automated devices can allow a reduction of health-care burden.
Detailed description
Epidural analgesia is recognized as the most effective technique to control labor pain, although its possible adverse events. Continuous epidural administration of local anesthetics can stabilize the analgesic block and reduce the anesthesiologists' workload but is associated with an increase in operative vaginal delivery. Epidural intermittent boluses performed by anesthetist are associated to reduction of dosages, but they could provide insufficient analgesia and they involve the constant anesthetist's presence in the operating room. This is a multicenter randomized controlled trial with two arms, funded by grant of Regione Emilia Romagna, in which we will compare two different epidural analgesia protocols: anesthesiologist's supervised versus intermittent boluses with PCEA.
Interventions
Programmed epidural bolus of 10 ml mixture every 75 minutes, plus patient controlled bolus of 5 ml same mixture; lock-out 15 minutes.
OTHERManual epidural bolus
Epidural bolus of 15 ml levobupivacaine and sufentanyl 10 mcg or 5 mcg administered by anesthesist on maternal request.
DRUGLevobupivacaine
Levobupivacaine 0,0625% through peridural catheter
DRUGSufentanil 4 mcg
Sufentanil 0,4 mcg/ml through peridural catheter
DRUGSufentanil 5 mcg
Sufentanil 5 mcg through peridural catheter
Sponsors
University of Modena and Reggio Emilia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Nulliparous women at full-term pregnancy single fetus and vertex presentation, hospitalized for harbingers of labor and cervical dilation less than 5 cm 2. Numeric Rate Scale \> 5
Exclusion criteria
1. patients aged under 18 years 2. patients with ongoing administration of oxytocin 3. patients with no indications to epidural analgesia 4. patients with inability to place the epidural catheter for technical difficulty 5. patients with parenteral administration of opioids 6. multiparous women 7. patients unable to understand the objectives and procedures of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of instrumental delivery | Through labor completion | Vaginal delivery obtained through vacuum device intervention decided independently by the obstetrician on duty, according to defined local protocols and according to the conditions of the mother and fetus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total amount of local anesthetic | Labor length since peridural catheter insertion until delivery | Total amount of levobupivacaine (mg) |
| Time-related amount of local anesthetic | Labor length since peridural catheter insertion until delivery | Amount of levobupivacaine for minute of analgesia (mg/min) |
| Adequate analgesia | Labor length since peridural catheter insertion until delivery | Mean Numeric Rate Scale values \< 5 through labor analgesia |
| Anesthesiologist working time | Labor length since peridural catheter insertion until delivery | Total time spent in labor room by anesthesiologist (minutes) |
| Health economic assessment | Labor length since peridural catheter insertion until delivery | Total epidural analgesia charge |
| Motor block episodes | Labor length since peridural catheter insertion until delivery | Number of patients with motor block episodes, defined by modified Bromage score \>1 |
Countries
Italy
Outcome results
None listed