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Comparison of Regimens VAMB, CIPCEA, PCEA (COLEUS)

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ClinicalTrials.gov Identifier: NCT02278601
Recruitment Status : Recruiting
First Posted : October 30, 2014
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
KK Women's and Children's Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Breakthrough Pain Device: epidural delivery system Drug: Ropivacaine Drug: Fentanyl Phase 3

Detailed Description:
The research team developed two novel epidural delivery regimens: computer-integrated PCEA (CIPCEA) (variable flexible background infusion) and variable-frequency automated mandatory bolus (VAMB) 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, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 839 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Variable-frequency Automated Mandatory Bolus (VAMB), Computer-integrated Patient Controlled Epidural Analgesia (CIPCEA) and Conventional Patient Controlled Epidural Analgesia (PCEA) During Labour
Actual Study Start Date : January 28, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VAMB variable automated
variable frequency automated mandatory bolus (VAMB) up-down frequency of 5mls ropivacaine/fentanyl solution in bolus with epidural delivery system
Device: epidural delivery system
epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution

Drug: Ropivacaine
epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution
Other Name: amide local anaesthetic

Drug: Fentanyl
epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution
Other Name: opioid

Experimental: CIPCEA
computer integrated patient controlled epidural analgesia (CIPCEA) up-down variable basal infusion of ropivacaine/fentanyl solution with epidural delivery system
Device: epidural delivery system
epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution

Drug: Ropivacaine
epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution
Other Name: amide local anaesthetic

Drug: Fentanyl
epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution
Other Name: opioid

Active Comparator: patient controlled epidural analgesia
patient controlled epidural analgesia (PCEA) with fixed basal infusion of ropivacaine/fentanyl solution with epidural delivery system
Device: epidural delivery system
epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution

Drug: Ropivacaine
epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution
Other Name: amide local anaesthetic

Drug: Fentanyl
epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution
Other Name: opioid




Primary Outcome Measures :
  1. Number of subjects with Breakthrough pain [ Time Frame: 1 day ]
    Unscheduled epidural supplementation by anaesthetist due to pain


Secondary Outcome Measures :
  1. Number of subjects with Caesarean section [ Time Frame: 1 day ]
    Number of subjects with Caesarean section

  2. Number of subjects with Instrumental delivery [ Time Frame: 1 day ]
    Number of subjects with Instrumental delivery (forceps, vacuum delivery)

  3. Foetal outcome [ Time Frame: 1 day ]
    APGAR scores

  4. Willingness to pay [ Time Frame: 1 day ]
    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)

  5. Factors associated with epidural decisions [ Time Frame: 1 day ]
    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.

  6. Pain vulnerability: Pain Catastrophizing Scale [ Time Frame: 1 day ]
    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).

  7. Edinburgh Postnatal Depression Scale before and after delivery [ Time Frame: 5-9 weeks ]
    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.



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Healthy (ASA physical status 1 and 2) nulliparous parturients at term (≥36 weeks gestation);
  2. Singleton foetus
  3. Early labour (cervical dilation ≤5cm)
  4. Request labour epidural analgesia
  5. At least 21 years of age

Exclusion Criteria:

  1. parturients with multiple pregnancies
  2. non-cephalic foetal presentation
  3. obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes, gestational diabetes on insulin) and uncontrolled medical (e.g. cardiac disease) complications
  4. have contraindications to neuraxial blockade or have received parenteral opioids with the last 2 hours.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278601


Contacts
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Contact: Ban L Sng, FANZCA +6563941081 sng.ban.leong@kkh.com.sg
Contact: Alex T Sia, MMED+ +6563941081 Alex.Sia.TH@kkh.com.sg

Locations
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Singapore
KK Women's and Children's Hospital Recruiting
Singapore, Singapore, 229899
Contact: Ban L Sng, FANZCA    +6563941081    sng.ban.leong@kkh.com.sg   
Contact: Alex T Sia, MD    +6563941081    alex.sia.th@kkh.com.sg   
Principal Investigator: Ban L Sng, FANZCA         
Sponsors and Collaborators
KK Women's and Children's Hospital
Investigators
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Principal Investigator: Ban L Sng, FANZCA KK Women's and Children's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT02278601    
Other Study ID Numbers: CTGL13feb013
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: January 2019
Keywords provided by KK Women's and Children's Hospital:
Breakthrough pain
Additional relevant MeSH terms:
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Breakthrough Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Anesthetics
Ropivacaine
Anesthetics, Local
Pharmaceutical Solutions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General