Akershus UH
Lørenskog, Akershus, 1478, Norway
NCT Number: NCT03043781
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Lørenskog, Akershus, 1478, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous infusion, 5 ml/h
Intermittent bolus 5 ml every hour
Time frame: 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.)
Time frame: 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.
Time frame: One assessment, within 24 hours of end of treatment
Mode of delivery will be assessed and categorized as vaginal,instrumentally assisted or cesarean delivery.
Time frame: 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
Time frame: During treatment (0-24 hours)
The need for additional anesthesiologic intervention, including time to this intervention from start of treatment.
Time frame: 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).
Time frame: 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.
University Hospital, Akershus
Other
Acronym: PIEBA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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