Labor PainPIEBANCT03043781
The Programmed Intermittent Epidural Bolus Adrenaline Study
A study testing Continuous epidural infusion and Intermittent epidural bolus in people with Labor Pain, run by University Hospital, Akershus at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Continuous epidural infusion and Intermittent epidural bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- 20 Mar 2017to 5 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Labor Pain
- Being tested
- Continuous epidural infusion, Intermittent epidural bolus
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous epidural infusionOther
Continuous infusion, 5 ml/h
Intermittent epidural bolusOther
Intermittent bolus 5 ml every hour
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intermittent epidural bolus |
| 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. Receives: Other: Continuous epidural infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: One assessment, within 24 hours of end of treatment
Secondary outcomes (6)
Maternal satisfaction with treatment
Overall satisfaction with treatment will be assessed the day after end of treatment on a 0-10 scale.
Measured: One assessment, within 24 hours of end of treatment
Mode of delivery
Mode of delivery will be assessed and categorized as vaginal,instrumentally assisted or cesarean delivery.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: During treatment (0-24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start20 Mar 2017
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vegard Dahl, University Hospital, Akershus
- Investigators
- Vegard Dahl, MD, Dr. Med., Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043781
- Sponsor's protocol ID
- 2015-004397-14
- Other IDs
- 2015
- Acronym
- PIEBA
- Status last verified
- Sep 2018
- First submitted
- 31 Jan 2017
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data.
Publications
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.
PubMed 23223119
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Programmed Intermittent Epidural Bolus Adrenaline Study
- ClinicalTrials.gov ID
- NCT03043781
- Acronym / sponsor ID
- PIEBA / 2015-004397-14
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent epidural bolus (IEB) | Experimental | Other: Intermittent epidural bolusBolus 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 | Other: Continuous epidural infusionContinuous 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous epidural infusionContinuous infusion, 5 ml/h | Other | Continuous epidural infusion (CEI) |
| Intermittent epidural bolusIntermittent bolus 5 ml every hour | Other | Intermittent epidural bolus (IEB) |
Primary outcome
Cumulative drug consumption, time adjusted
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.)
6 secondary outcomes
Maternal satisfaction with treatment
Time frame: One assessment, within 24 hours of end of treatment
Mode of delivery
Time frame: One assessment, within 24 hours of end of treatment
Motor block
Time frame: One assessment at one hour after treatment initiation and one at 10 cm cervical dilatation.
Anesthesiologic intervention
Time frame: During treatment (0-24 hours)
Incidence of expected adverse events
Time frame: Adverse events during treatment (0-24 hours) and final assessment within 24 hours of end of treatment
Pain rating
Time frame: During treatment (0-24 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Background: PubMed 23223119George 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.
- Individual participant dataSharing planned: No. No plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vegard Dahl, MD, Dr. Med. principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous epidural infusion and Intermittent epidural bolus in people with Labor Pain, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative drug consumption, time adjusted (time frame: One assessment, within 24 hours of end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03043781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.