Labor PainNCT03730753
Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia
A study testing Programmed intermittent epidural bolus and Continuous infusion in people with Labor Pain, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
This study aims to establish if programmed intermittent epidural bolus combined to patient controlled analgesia in labour analgesia will lower the hourly bupivacaine consumption when compared to continuous infusion combined with patient controlled analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Programmed intermittent epidural bolus and Continuous infusion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2019to 30 Jun 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant nulliparous or multiparous woman in labour
- Age ≥18 years
- Obtained consent for epidural analgesia
- ASA classification I-II-III
- Early labour (cervical dilation ≤6cm)
Who cannot join
- Pregnancy-related comorbidities (preeclampsia, eclampsia, gestational diabetes, large for gestational age fetus)
- Prematurity (<36 weeks of gestation)
- Multiple gestation
- Fentanyl allergy or hypersensitivity
- Patient unable to understand the PCEA
- Fetal breech position
Show all 12Show fewer
- Maternal cardiac pathology and contraindication to Valsalva manoeuvre
- Patient with a pain visual analog scale (VAS) not ≤1/10 20 minutes after the anesthesiologist's initial bolus
- Intrathecal catheter or intravascular catheter
- Accidental dural puncture
- Patient refusal
- Patient with a history of chronic pain (pain lasting more than 3 months) or fibromyalgia
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHUS
Sherbrooke, Quebec, J1H5N4
Genevieve Rivard, FRCPC, 8195651502, genevieve.rivard2@usherbrooke.ca
Isabelle Caron, isabelle.caron4@usherbrooke.ca
About this study
Official title: Programmed Intermittent Epidural Bolus Versus Continuous Infusion When Added to Patient-controlled Epidural Analgesia on Bupivacaine Consumption in Labour Analgesia: a Randomized Controlled Trial
This study aims to establish if programmed intermittent epidural bolus combined to patient controlled analgesia in labour analgesia will lower the hourly bupivacaine consumption when compared to continuous infusion combined with patient controlled analgesia. The investigators' hypothesis is that the use of programmed intermittent epidural bolus will lower the hourly bupivacaine consumption.
Read the detailed description
Patients are randomised to receive either a programmed bolus of 6ml each 45 minutes or a continuous infusion of 8ml/h. In each group, they have the possibility to add a PCEA bolus of 6ml every 20min as needed.
- Conditions
- Labor Pain
- Being tested
- Programmed intermittent epidural bolus, Continuous infusion
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programmed intermittent epidural bolusDevice
Programmed intermittent epidural bolus added to patient controlled epidural analgesia
Continuous infusionDevice
Continuous infusion added to patient controlled epidural analgesia
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Continuous infusion + patient controlled epidural analgesia Receives: Device: Continuous infusion |
| Study group | Experimental | Programmed intermittent epidural bolus + patient controlled analgesia Receives: Device: Programmed intermittent epidural bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of bupivacaine in milligrams per hour
Total dose of bupivacaine in milligrams divided by the total duration of the epidural in hours
Measured: 1 day
Secondary outcomes (11)
Evaluation of pain
Hourly pain measurement by visual analog scale, 0/10 being no pain and 10/10 being the worst pain imaginable
Measured: 1 day
Anesthesiologist manual bolus
Total boluses by the anesthesiologist
Measured: 1 day
PCEA boluses received
PCEA boluses received
Measured: 1 day
PCEA boluses requested
PCEA boluses requested
Measured: 1 day
Time lapse before the first PCEA request after the epidural connection
Time lapse before the first PCEA request after the epidural connection
Measured: 1 day
First stage
Duration of the first stage of labour
Measured: 1 day
Second stage
Duration of the second stage of labour
Measured: 1 day
Assisted vaginal delivery
Number of assisted vaginal delivery (vacuum, forceps)
Measured: 1 day
Cesarean section
Number of unplanned cesarean section
Measured: 1 day
Motor blockade
Number of patients with a Bromage score ≥1
Measured: 1 day
Patient satisfaction
Satisfaction of the analgesia provided by the epidural on a visual analog scale of 0-100, 0/100 being no satisfaction at all and 100/100 being entirely satisfied
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Jun 2019
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geneviève Rivard, Université de Sherbrooke
- Investigators
- Geneviève Rivard, Dr., Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730753
- Sponsor's protocol ID
- 2018 - 2686
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2018
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Liu EH, Sia AT. Rates of caesarean section and instrumental vaginal delivery in nulliparous women after low concentration epidural infusions or opioid analgesia: systematic review. BMJ. 2004 Jun 12;328(7453):1410. doi: 10.1136/bmj.38097.590810.7C. Epub 2004 May 28.
PubMed 15169744Nunes J, Nunes S, Veiga M, Cortez M, Seifert I. A prospective, randomized, blinded-endpoint, controlled study - continuous epidural infusion versus programmed intermittent epidural bolus in labor analgesia. Braz J Anesthesiol. 2016 Sep-Oct;66(5):439-44. doi: 10.1016/j.bjane.2014.12.006. Epub 2015 Nov 19.
PubMed 27591455Salim R, Nachum Z, Moscovici R, Lavee M, Shalev E. Continuous compared with intermittent epidural infusion on progress of labor and patient satisfaction. Obstet Gynecol. 2005 Aug;106(2):301-6. doi: 10.1097/01.AOG.0000171109.53832.8d.
PubMed 16055579Chua SM, Sia AT. Automated intermittent epidural boluses improve analgesia induced by intrathecal fentanyl during labour. Can J Anaesth. 2004 Jun-Jul;51(6):581-5. doi: 10.1007/BF03018402.
PubMed 15197122Lim Y, Sia AT, Ocampo C. Automated regular boluses for epidural analgesia: a comparison with continuous infusion. Int J Obstet Anesth. 2005 Oct;14(4):305-9. doi: 10.1016/j.ijoa.2005.05.004.
PubMed 16154735Lim Y, Chakravarty S, Ocampo CE, Sia AT. Comparison of automated intermittent low volume bolus with continuous infusion for labour epidural analgesia. Anaesth Intensive Care. 2010 Sep;38(5):894-9. doi: 10.1177/0310057X1003800514.
PubMed 20865875Fettes PD, Moore CS, Whiteside JB, McLeod GA, Wildsmith JA. Intermittent vs continuous administration of epidural ropivacaine with fentanyl for analgesia during labour. Br J Anaesth. 2006 Sep;97(3):359-64. doi: 10.1093/bja/ael157. Epub 2006 Jul 18.
PubMed 16849382Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9. doi: 10.1213/01.ane.0000197778.57615.1a.
PubMed 16492849Leo S, Ocampo CE, Lim Y, Sia AT. A randomized comparison of automated intermittent mandatory boluses with a basal infusion in combination with patient-controlled epidural analgesia for labor and delivery. Int J Obstet Anesth. 2010 Oct;19(4):357-64. doi: 10.1016/j.ijoa.2010.07.006. Epub 2010 Sep 15.
PubMed 20832282Tien M, Allen TK, Mauritz A, Habib AS. A retrospective comparison of programmed intermittent epidural bolus with continuous epidural infusion for maintenance of labor analgesia. Curr Med Res Opin. 2016 Aug;32(8):1435-40. doi: 10.1080/03007995.2016.1181619. Epub 2016 May 20.
PubMed 27100210Sia AT, Lim Y, Ocampo C. A comparison of a basal infusion with automated mandatory boluses in parturient-controlled epidural analgesia during labor. Anesth Analg. 2007 Mar;104(3):673-8. doi: 10.1213/01.ane.0000253236.89376.60.
PubMed 17312228Capogna G, Camorcia M, Stirparo S, Farcomeni A. Programmed intermittent epidural bolus versus continuous epidural infusion for labor analgesia: the effects on maternal motor function and labor outcome. A randomized double-blind study in nulliparous women. Anesth Analg. 2011 Oct;113(4):826-31. doi: 10.1213/ANE.0b013e31822827b8. Epub 2011 Jul 25.
PubMed 21788309McKenzie CP, Cobb B, Riley ET, Carvalho B. Programmed intermittent epidural boluses for maintenance of labor analgesia: an impact study. Int J Obstet Anesth. 2016 May;26:32-8. doi: 10.1016/j.ijoa.2015.11.005. Epub 2015 Nov 27.
PubMed 26775896Epsztein Kanczuk M, Barrett NM, Arzola C, Downey K, Ye XY, Carvalho JC. Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: A Biased-Coin Up-and-Down Sequential Allocation Trial to Determine the Optimum Interval Time Between Boluses of a Fixed Volume of 10 mL of Bupivacaine 0.0625% With Fentanyl 2 mug/mL. Anesth Analg. 2017 Feb;124(2):537-541. doi: 10.1213/ANE.0000000000001655.
PubMed 27755057Wong CA, McCarthy RJ, Hewlett B. The effect of manipulation of the programmed intermittent bolus time interval and injection volume on total drug use for labor epidural analgesia: a randomized controlled trial. Anesth Analg. 2011 Apr;112(4):904-11. doi: 10.1213/ANE.0b013e31820e7c2f.
PubMed 21430035
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programmed Intermittent Epidural Bolus Versus Continuous Infusion When Added to Patient-controlled Epidural Analgesia on Bupivacaine Consumption in Labour Analgesia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03730753
- Acronym / sponsor ID
- 2018 - 2686
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 5 Nov 2018 (actual)
- 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 aims to establish if programmed intermittent epidural bolus combined to patient controlled analgesia in labour analgesia will lower the hourly bupivacaine consumption when compared to continuous infusion combined with patient controlled analgesia. The investigators' hypothesis is that the use of programmed intermittent epidural bolus will lower the hourly bupivacaine consumption.
Detailed description
Patients are randomised to receive either a programmed bolus of 6ml each 45 minutes or a continuous infusion of 8ml/h. In each group, they have the possibility to add a PCEA bolus of 6ml every 20min as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Continuous infusionContinuous infusion + patient controlled epidural analgesia |
| Study group | Experimental | Device: Programmed intermittent epidural bolusProgrammed intermittent epidural bolus + patient controlled analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant nulliparous or multiparous woman in labour
- Age ≥18 years
- Obtained consent for epidural analgesia
- ASA classification I-II-III
- Early labour (cervical dilation ≤6cm)
Key exclusion criteria (12 listed)
- Pregnancy-related comorbidities (preeclampsia, eclampsia, gestational diabetes, large for gestational age fetus)
- Prematurity (<36 weeks of gestation)
- Multiple gestation
- Fentanyl allergy or hypersensitivity
- Patient unable to understand the PCEA
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 |
|---|---|---|
| Programmed intermittent epidural bolusProgrammed intermittent epidural bolus added to patient controlled epidural analgesia | Device | Study group |
| Continuous infusionContinuous infusion added to patient controlled epidural analgesia | Device | Control group |
Primary outcome
Dose of bupivacaine in milligrams per hour
Time frame: 1 day
Total dose of bupivacaine in milligrams divided by the total duration of the epidural in hours
11 secondary outcomes
Evaluation of pain
Time frame: 1 day
Anesthesiologist manual bolus
Time frame: 1 day
PCEA boluses received
Time frame: 1 day
PCEA boluses requested
Time frame: 1 day
Time lapse before the first PCEA request after the epidural connection
Time frame: 1 day
First stage
Time frame: 1 day
Second stage
Time frame: 1 day
Assisted vaginal delivery
Time frame: 1 day
Cesarean section
Time frame: 1 day
Motor blockade
Time frame: 1 day
Patient satisfaction
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Background: PubMed 15169744Liu EH, Sia AT. Rates of caesarean section and instrumental vaginal delivery in nulliparous women after low concentration epidural infusions or opioid analgesia: systematic review. BMJ. 2004 Jun 12;328(7453):1410. doi: 10.1136/bmj.38097.590810.7C. Epub 2004 May 28.
- Background: PubMed 27591455Nunes J, Nunes S, Veiga M, Cortez M, Seifert I. A prospective, randomized, blinded-endpoint, controlled study - continuous epidural infusion versus programmed intermittent epidural bolus in labor analgesia. Braz J Anesthesiol. 2016 Sep-Oct;66(5):439-44. doi: 10.1016/j.bjane.2014.12.006. Epub 2015 Nov 19.
- Background: PubMed 16055579Salim R, Nachum Z, Moscovici R, Lavee M, Shalev E. Continuous compared with intermittent epidural infusion on progress of labor and patient satisfaction. Obstet Gynecol. 2005 Aug;106(2):301-6. doi: 10.1097/01.AOG.0000171109.53832.8d.
- Background: PubMed 15197122Chua SM, Sia AT. Automated intermittent epidural boluses improve analgesia induced by intrathecal fentanyl during labour. Can J Anaesth. 2004 Jun-Jul;51(6):581-5. doi: 10.1007/BF03018402.
- Background: PubMed 16154735Lim Y, Sia AT, Ocampo C. Automated regular boluses for epidural analgesia: a comparison with continuous infusion. Int J Obstet Anesth. 2005 Oct;14(4):305-9. doi: 10.1016/j.ijoa.2005.05.004.
- Background: PubMed 20865875Lim Y, Chakravarty S, Ocampo CE, Sia AT. Comparison of automated intermittent low volume bolus with continuous infusion for labour epidural analgesia. Anaesth Intensive Care. 2010 Sep;38(5):894-9. doi: 10.1177/0310057X1003800514.
- Background: PubMed 16849382Fettes PD, Moore CS, Whiteside JB, McLeod GA, Wildsmith JA. Intermittent vs continuous administration of epidural ropivacaine with fentanyl for analgesia during labour. Br J Anaesth. 2006 Sep;97(3):359-64. doi: 10.1093/bja/ael157. Epub 2006 Jul 18.
- Background: PubMed 16492849Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9. doi: 10.1213/01.ane.0000197778.57615.1a.
- Background: PubMed 20832282Leo S, Ocampo CE, Lim Y, Sia AT. A randomized comparison of automated intermittent mandatory boluses with a basal infusion in combination with patient-controlled epidural analgesia for labor and delivery. Int J Obstet Anesth. 2010 Oct;19(4):357-64. doi: 10.1016/j.ijoa.2010.07.006. Epub 2010 Sep 15.
- Background: PubMed 27100210Tien M, Allen TK, Mauritz A, Habib AS. A retrospective comparison of programmed intermittent epidural bolus with continuous epidural infusion for maintenance of labor analgesia. Curr Med Res Opin. 2016 Aug;32(8):1435-40. doi: 10.1080/03007995.2016.1181619. Epub 2016 May 20.
- Background: PubMed 17312228Sia AT, Lim Y, Ocampo C. A comparison of a basal infusion with automated mandatory boluses in parturient-controlled epidural analgesia during labor. Anesth Analg. 2007 Mar;104(3):673-8. doi: 10.1213/01.ane.0000253236.89376.60.
- Background: PubMed 21788309Capogna G, Camorcia M, Stirparo S, Farcomeni A. Programmed intermittent epidural bolus versus continuous epidural infusion for labor analgesia: the effects on maternal motor function and labor outcome. A randomized double-blind study in nulliparous women. Anesth Analg. 2011 Oct;113(4):826-31. doi: 10.1213/ANE.0b013e31822827b8. Epub 2011 Jul 25.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Geneviève Rivard, Dr. principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Programmed intermittent epidural bolus and Continuous infusion in people with Labor Pain, run by Université de Sherbrooke at 1 site in Canada.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 30 Nov 2023. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Caron, Dr. (+1 819 346-1110 ext. 5593, isabelle.caron4@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of bupivacaine in milligrams per hour (time frame: 1 day). 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 NCT03730753, which also lists 19 linked publications.
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 30 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.