Breakthrough PainPhase 3COLEUSNCT02278601
Comparison of Regimens MPIB, CIPCEA, PCEA
A Phase 3 study testing epidural delivery system, Ropivacaine and Fentanyl in people with Breakthrough Pain, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Epidural analgesia is the gold standard of pain relief for labour pain. Despite this, more than 50% of parturients continue to experience pain leading to suffering and increased caregiver workload. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Breakthrough Pain
- What is being tested?
- epidural delivery system, Ropivacaine and Fentanyl
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 839 participants
- Where
- 1 siteSingapore
- Study dates
- 28 Jan 2015to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 21 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy (ASA physical status 1 and 2) nulliparous parturients at term (≥36 weeks gestation);
- Singleton foetus
- Early labour (cervical dilation ≤5cm)
- Request labour epidural analgesia
- At least 21 years of age
Who cannot join
- parturients with multiple pregnancies
- non-cephalic foetal presentation
- obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes, gestational diabetes on insulin) and uncontrolled medical (e.g. cardiac disease) complications
- have contraindications to neuraxial blockade or have received parenteral opioids with the last 2 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Modified Programmed Intermittent Bolus (MPIB), Computer-integrated Patient Controlled Epidural Analgesia (CIPCEA) and Conventional Patient Controlled Epidural Analgesia (PCEA) During Labour
Epidural analgesia is the gold standard of pain relief for labour pain. Despite this, more than 50% of parturients continue to experience pain leading to suffering and increased caregiver workload. Women who have increased pain tend to have lower successful patient bolus demands when patient controlled epidural analgesia (PCEA) is utilised and have dysfunctional labour requiring obstetric intervention such as Caesarean or instrumental delivery. Labour pain often escalates and worsens as labour progresses requiring an individualized, variable, flexible analgesic regimen. Bolus epidural administrations have been shown to improve uniform spread of local anaesthetics with better pain relief, compared to fixed background infusions.
Read the detailed description
The research team developed two novel epidural delivery regimens: computer-integrated PCEA (CIPCEA) and modified programmed intermittent bolus (MPIB) focused on individualization of analgesic requirements. This phase 3 double-blinded randomized controlled trial will compare the two novel regimens, and each with conventional PCEA with basal infusion (BI), in reducing breakthrough pain (failure of the regimen to provide adequate pain relief, necessitating unscheduled epidural supplementation) incidence as the primary outcome in nulliparous term women requesting labour epidural analgesia. In addition, a discrete choice experiment (DCE) in the format of a survey will be administered to estimate the women's preferences in treatment attributes related to epidural analgesia, including control over epidural dosage, chance of having breakthrough pain, motor block, instrumental delivery and out-of-pocket cost for epidural analgesia. We will also look into the association model for breakthrough pain that would take into account pre-delivery factors to better understand the mechanism of breakthrough pain during labor process.
- Conditions
- Breakthrough Pain
- Being tested
- epidural delivery system, Ropivacaine, Fentanyl
- Keywords
- Breakthrough pain
- Medical subject headings
- Breakthrough Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural delivery systemDevice
epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution
RopivacaineDrug
Also called amide local anaesthetic
epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution
FentanylDrug
Also called opioid
epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution
| Study group | Role | What they receive |
|---|---|---|
| MPIB modified programmed intermittent bolus | Experimental | Modified programmed intermittent bolus (MPIB) up-down frequency of 5mls ropivacaine/fentanyl solution in bolus with epidural delivery system Receives: Device: epidural delivery system; Drug: Ropivacaine; Drug: Fentanyl |
| CIPCEA | Experimental | computer integrated patient controlled epidural analgesia (CIPCEA) up-down variable basal infusion of ropivacaine/fentanyl solution with epidural delivery system Receives: Device: epidural delivery system; Drug: Ropivacaine; Drug: Fentanyl |
| patient controlled epidural analgesia with basal infusion | Active comparator | patient controlled epidural analgesia (PCEA) with fixed basal infusion of ropivacaine/fentanyl solution with epidural delivery system Receives: Device: epidural delivery system; Drug: Ropivacaine; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Breakthrough pain
Unscheduled epidural supplementation by anaesthetist due to pain
Measured: 1 day
Secondary outcomes (8)
Number of subjects with Caesarean section
Number of subjects with Caesarean section
Measured: 1 day
Number of subjects with Instrumental delivery
Number of subjects with Instrumental delivery (forceps, vacuum delivery)
Measured: 1 day
Foetal outcome
APGAR scores
Measured: 1 day
Willingness to pay
Discrete choice experiments (DCE) in survey format will be given to patients to determine patient's mean willingness to pay for epidural features, including control over epidural dosage, chance of having breakthrough pain, motor block, instrumental delivery and out-of-pocket cost for epidural analgesia)
Measured: 1 day
Factors associated with epidural decisions
Participants will be exposed to 8 pairs of hypothetical medical scenarios as per the design of DCE. Participants have to choose the ideal scenario (A or B) that provides the highest perceived benefits. Each pair of scenarios represents a comprehensive combination of possible attributes related to epidural analgesia, including control over epidural dosage, chance of having breakthrough pain, motor block, instrumental delivery and out-of-pocket cost for epidural analgesia. The most common factors associated with optimal perceived benefits will be assessed based on these experimental design. A weighted estimate will be calculated for each attribute.
Measured: 1 day
Pain vulnerability: Pain Catastrophizing Scale
Assessment will be done via Pain Catastrophizing Scale (PCS) questionnaire before delivery. Pain catastrophizing refers to the negative thought processes patients have when they are exposed to pain or painful experiences. The PCS is a 13-item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). It is broken into three subscales being magnification (0-12), rumination (0-16), and helplessness (0-24). A higher value in each subscale indicates a higher tendency to that subscale (worse outcome).
Measured: 1 day
Edinburgh Postnatal Depression Scale before and after delivery
Assessment will be done via Edinburgh Postnatal Depression Scale (EPDS) before delivery, and again 5 to 9 weeks after delivery to assess patient's status on postnatal depression. The EPDS is a 10 item self-reported questionnaire validated for use as a screening tool for antenatal and postpartum depression in the clinical setting. Participants are asked to respond according to how they have felt in the past seven days, by which the questions correspond to common depressive symptoms. Each item is measured on a 4-point scale, with a total score in the range of 0 to 30. A higher total score indicates a greater degree of depressive symptoms. A score of 13 and above indicates clinically significant depressive symptom.
Measured: 5-9 weeks
Sub-acute pain after childbirth
Assessment will be done via a pain survey at 5-9 weeks after delivery to ask on patient's pain experience, including the presence of sub-acute pain after childbirth, defined by presence or absence of pain that lasted for 4 weeks or more) (binary variable with categories "yes" or "no").
Measured: 5-9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study start28 Jan 2015
- Primary completion6 May 2019
- Study completion31 Dec 2027 (estimated)
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 Breakthrough PainStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 839 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
- Investigators
- Ban L Sng, FANZCA, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278601
- Sponsor's protocol ID
- CTGL13feb013
- Acronym
- COLEUS
- Status last verified
- Aug 2026
- First submitted
- 26 Oct 2014
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Tan DJA, Lew JP, Jumhasan MB, Pang C, Sultana R, Sng BL. Investigating factors associated with success of breastfeeding in first-time mothers undergoing epidural analgesia: a prospective cohort study. Int Breastfeed J. 2018 Sep 5;13:42. doi: 10.1186/s13006-018-0184-7. eCollection 2018.
PubMed 30202425
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Modified Programmed Intermittent Bolus (MPIB), Computer-integrated Patient Controlled Epidural Analgesia (CIPCEA) and Conventional Patient Controlled Epidural Analgesia (PCEA) During Labour
- ClinicalTrials.gov ID
- NCT02278601
- Acronym / sponsor ID
- COLEUS / CTGL13feb013
- Conditions
- Breakthrough Pain
- Keywords
- Breakthrough pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 839 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 28 Jan 2015 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Oct 2014 (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.
Epidural analgesia is the gold standard of pain relief for labour pain. Despite this, more than 50% of parturients continue to experience pain leading to suffering and increased caregiver workload. Women who have increased pain tend to have lower successful patient bolus demands when patient controlled epidural analgesia (PCEA) is utilised and have dysfunctional labour requiring obstetric intervention such as Caesarean or instrumental delivery. Labour pain often escalates and worsens as labour progresses requiring an individualized, variable, flexible analgesic regimen. Bolus epidural administrations have been shown to improve uniform spread of local anaesthetics with better pain relief, compared to fixed background infusions.
Detailed description
The research team developed two novel epidural delivery regimens: computer-integrated PCEA (CIPCEA) and modified programmed intermittent bolus (MPIB) focused on individualization of analgesic requirements. This phase 3 double-blinded randomized controlled trial will compare the two novel regimens, and each with conventional PCEA with basal infusion (BI), in reducing breakthrough pain (failure of the regimen to provide adequate pain relief, necessitating unscheduled epidural supplementation) incidence as the primary outcome in nulliparous term women requesting labour epidural analgesia. In addition, a discrete choice experiment (DCE) in the format of a survey will be administered to estimate the women's preferences in treatment attributes related to epidural analgesia, including control over epidural dosage, chance of having breakthrough pain, motor block, instrumental delivery and out-of-pocket cost for epidural analgesia. We will also look into the association model for breakthrough pain that would take into account pre-delivery factors to better understand the mechanism of breakthrough pain during labor process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MPIB modified programmed intermittent bolus | Experimental | Device: epidural delivery system, Drug: Ropivacaine, Drug: FentanylModified programmed intermittent bolus (MPIB) up-down frequency of 5mls ropivacaine/fentanyl solution in bolus with epidural delivery system |
| CIPCEA | Experimental | Device: epidural delivery system, Drug: Ropivacaine, Drug: Fentanylcomputer integrated patient controlled epidural analgesia (CIPCEA) up-down variable basal infusion of ropivacaine/fentanyl solution with epidural delivery system |
| patient controlled epidural analgesia with basal infusion | Active comparator | Device: epidural delivery system, Drug: Ropivacaine, Drug: Fentanylpatient controlled epidural analgesia (PCEA) with fixed basal infusion of ropivacaine/fentanyl solution with epidural delivery system |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy (ASA physical status 1 and 2) nulliparous parturients at term (≥36 weeks gestation);
- Singleton foetus
- Early labour (cervical dilation ≤5cm)
- Request labour epidural analgesia
- At least 21 years of age
Key exclusion criteria (4 listed)
- parturients with multiple pregnancies
- non-cephalic foetal presentation
- obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes, gestational diabetes on insulin) and uncontrolled medical (e.g. cardiac disease) complications
- have contraindications to neuraxial blockade or have received parenteral opioids with the last 2 hours.
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 |
|---|---|---|
| epidural delivery systemepidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution | Device | CIPCEA, MPIB modified programmed intermittent bolus, patient controlled epidural analgesia with basal infusion |
| RopivacaineAlso: amide local anaestheticepidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution | Drug | CIPCEA, MPIB modified programmed intermittent bolus, patient controlled epidural analgesia with basal infusion |
| FentanylAlso: opioidepidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution | Drug | CIPCEA, MPIB modified programmed intermittent bolus, patient controlled epidural analgesia with basal infusion |
Primary outcome
Number of subjects with Breakthrough pain
Time frame: 1 day
Unscheduled epidural supplementation by anaesthetist due to pain
8 secondary outcomes
Number of subjects with Caesarean section
Time frame: 1 day
Number of subjects with Instrumental delivery
Time frame: 1 day
Foetal outcome
Time frame: 1 day
Willingness to pay
Time frame: 1 day
Factors associated with epidural decisions
Time frame: 1 day
Pain vulnerability: Pain Catastrophizing Scale
Time frame: 1 day
Edinburgh Postnatal Depression Scale before and after delivery
Time frame: 5-9 weeks
Sub-acute pain after childbirth
Time frame: 5-9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Derived from this study: PubMed 30202425Tan DJA, Lew JP, Jumhasan MB, Pang C, Sultana R, Sng BL. Investigating factors associated with success of breastfeeding in first-time mothers undergoing epidural analgesia: a prospective cohort study. Int Breastfeed J. 2018 Sep 5;13:42. doi: 10.1186/s13006-018-0184-7. eCollection 2018.
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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.
Ban L Sng, FANZCA principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epidural delivery system, Ropivacaine and Fentanyl in people with Breakthrough Pain, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. 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 Singapore. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Number of subjects with Breakthrough pain (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 NCT02278601, 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 7 Aug 2026.