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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent epidural bolus (IEB) | Experimental | Bolus of 5 ml every hour + patient controlled extra boluses of 5 ml, maximum 3 / hour. Medicine solution is bupivacaine 1 mg/ml, fentanyl 2 mcg/ml, adrenaline 2 mcg/ml. |
|
| Continuous epidural infusion (CEI) | Active Comparator | Continuous epidural infusion of 5 ml / hour + patient controlled extra boluses of 5 ml, maximum 3 / hour. Medicine solution is bupivacaine 1 mg/ml, fentanyl 2 mcg/ml, adrenaline 2 mcg/ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous epidural infusion | Other | Continuous infusion, 5 ml/h |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative drug consumption, time adjusted | 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.) | One assessment, within 24 hours of end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal satisfaction with treatment | Overall satisfaction with treatment will be assessed the day after end of treatment on a 0-10 scale. | One assessment, within 24 hours of end of treatment |
| Mode of delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vegard Dahl, MD, Dr. Med. | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus UH | Lørenskog | Akershus | 1478 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23223119 | Background | George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7. |
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No plan to share individual participant data.
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Intermittent epidural bolus |
| Other |
Intermittent bolus 5 ml every hour |
|
Mode of delivery will be assessed and categorized as vaginal,instrumentally assisted or cesarean delivery.
| One assessment, within 24 hours of end of treatment |
| Motor block | Extent of lower extremity motor block will be assessed using a modified Bromage score | One assessment at one hour after treatment initiation and one at 10 cm cervical dilatation. |
| Anesthesiologic intervention | The need for additional anesthesiologic intervention, including time to this intervention from start of treatment. | During treatment (0-24 hours) |
| Incidence of expected adverse events | Expected adverse events include hypotension (systolic blood pressure < 90 mmHg and/or use of vasopressors), nausea (mild/moderate/severe) and pruritus (mild/moderate/severe). | Adverse events during treatment (0-24 hours) and final assessment within 24 hours of end of treatment |
| Pain rating | 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. | During treatment (0-24 hours) |