Labor Pain
Conditions
Brief summary
This study evaluates the use of intermittent epidural boluses compared to continuous infusion in maintaining epidural pain relief in labor. The medicine solution used contains, in addition to bupivacain and fentanyl, adrenalin in both groups.
Detailed description
Labor is often painful for the woman going through it, and thus many women choose to have pain relief by an epidural catheter. This is done by placing a thin plastic catheter in the epidural space in the lower back of the patient, and injecting a medicine solution usually consisting of local anesthesia and opioids. To ensure an effective pain relief through the labor process, additional medicine solution is injected through the catheter. Traditionally, this is done by a continuous infusion, often with the addition of patient controlled boluses. In this study the investigators investigate if maintaining the pain relief through programmed hourly intermittent boluses is more effective than continuous infusion. This is done in other studies with promising results, but the difference in this study is the addition of adrenaline to the medicine solution in order to make it more effective.
Interventions
Continuous infusion, 5 ml/h
Intermittent bolus 5 ml every hour
Sponsors
University Hospital, Akershus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant women in labor requesting epidural analgesia * ASA group 1 and 2 * 0 or 1 previous births * Must be at least 18 years of age. * Singleton pregnancy * Active labor * Signed informed consent and expected cooperation of the patient
Exclusion criteria
* Poor communication skills in norwegian or english * Adverse reactions to local anesthetics or synthetic opioids * Body height below 150 cm * Gestational age below 37 weeks, 0 days * Any contraindication to epidural catheter placement (e.g. patients with coagulopathy, infection in area etc) * Pre-eclampsia * Sound reason by the investigator to suspect patient non-compliance (e.g. with use of PCEA)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative drug consumption, time adjusted | One assessment, within 24 hours of end of treatment | Cumulative drug consumption is assessed at the end of treatment (at birth). The total dose is adjusted for differences in treatment time and other possible factors of influence (BMI, parity, age, gestational age etc.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mode of delivery | One assessment, within 24 hours of end of treatment | Mode of delivery will be assessed and categorized as vaginal,instrumentally assisted or cesarean delivery. |
| Motor block | One assessment at one hour after treatment initiation and one at 10 cm cervical dilatation. | Extent of lower extremity motor block will be assessed using a modified Bromage score |
| Maternal satisfaction with treatment | One assessment, within 24 hours of end of treatment | Overall satisfaction with treatment will be assessed the day after end of treatment on a 0-10 scale. |
| Incidence of expected adverse events | Adverse events during treatment (0-24 hours) and final assessment within 24 hours of end of treatment | Expected adverse events include hypotension (systolic blood pressure \< 90 mmHg and/or use of vasopressors), nausea (mild/moderate/severe) and pruritus (mild/moderate/severe). |
| Pain rating | During treatment (0-24 hours) | Pain rating will be assessed using a numeric rating scale (NRS, 0-10; 0= no pain, 10=worst imaginable pain) before treatment start, at every hour for the first 8 hours of treatment and every other hour thereafter. Worst pain at delivery will also be assessed. |
| Anesthesiologic intervention | During treatment (0-24 hours) | The need for additional anesthesiologic intervention, including time to this intervention from start of treatment. |
Countries
Norway
Outcome results
None listed