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Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour (VVAMB)

Primary Purpose

Labor Pain, Breakthrough Pain

Status
Recruiting
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Epidural infusion pump
Ropivacaine
Fentanyl
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Labor Pain, Breakthrough Pain, Infusion pump

Eligibility Criteria

21 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy (American Society of Anesthesiologists (ASA) physical status 1 and 2) primiparous parturient at term (≥36 weeks gestation);
  • Singleton fetus;
  • In early labor stage (cervical dilation ≤5cm);
  • Request labor epidural analgesia and able to administer combined spinal epidural analgesia (CSEA) according to protocol.

Exclusion Criteria:

  • Non-cephalic fetal presentation;
  • Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications;
  • Have contraindications to neuraxial blockade or have received parenteral opioids within last 2 hours;
  • Dural puncture/ suspected dural puncture at initiation of CSEA.

Sites / Locations

  • KK Women's and Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Variable volume Automated Mandatory Bolus (VVAMB)

Automated mandatory bolus (AMB) of variable-frequency (VAMB)

Arm Description

The anaesthetic drug and pain medication are prepared in an epidural infusion pump with the VVAMB programme. The programme uses higher doses with lower frequency of medication (ropivacaine and fentanyl), and a patient control button for the patient to control the additional pain relief demands depending on the requirements during labour.

The anaesthetic drug and pain medication are prepared in an epidural infusion pump with the VAMB programme. The programme uses lower doses with more frequency of medication (ropivacaine and fentanyl), and a patient control button for the patient to control the additional pain relief demands depending on the requirements during labour.

Outcomes

Primary Outcome Measures

Incidence of motor block in each group
The number of event of motor block throughout the labour. Previous studies have shown that epidural analgesia using high concentrations of local anaesthetics could lead to decreased motor functions, and are subsequently associated with an increased incidence of instrumented delivery and longer second stage of labour. In this study, the intensity of motor block is assessed by the patient's ability to move their lower extremities via a modified Bromage scale. In the modified version, a scoring of 0 implies no motor block (Free movement of both legs and feet), scoring of 1 implies partial block (Just able to flex knees with free movement of feet), 2 implies almost complete block (Unable to flex knees but with free movement of feet) and 3 implies a full block (Unable to move legs/ feet).

Secondary Outcome Measures

Number of subjects with Instrumental delivery
The number of subjects in each group having instrumental delivery (forceps, vacuum delivery)
Number of subjects with Breakthrough pain
The number of subjects in each group having unscheduled epidural supplementation by anaesthetist due to labor pain
APGAR score
The Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score is a test given to newborns soon after birth. In the test, five are being evaluated: Appearance (skin color), Pulse (heart rate), Grimace response (reflexes), Activity (muscle tone) and Respiration (breathing rate and effort). Each is scored on a scale of 0 to 2, with 2 being the best score; a total score of ten represents the best possible condition.

Full Information

First Posted
July 4, 2019
Last Updated
April 2, 2023
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04011150
Brief Title
Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour
Acronym
VVAMB
Official Title
Development of Variable Volume Automated Mandatory Boluses (VVAMB) for Patient-controlled Epidural Analgesia During Labour and Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A novel epidural delivery regimen was developed: Variable volume automated mandatory bolus (AMB) (VVAMB) will advance individualisation of labour epidural analgesia, by which a larger volume of bolus may contribute to better spread of the local anaesthetics within brief period and thereby reduces the chances of motor blockade that could reduce instrumental deliveries.
Detailed Description
Epidural analgesia is the gold standard of pain relief for labour pain. Despite this, up to 50% of parturients continue to experience pain leading to suffering and increased caregiver workload. There is also higher risk of motor blockade found in those receiving epidural analgesia, and these factors is associated with dysfunctional labour requiring obstetric intervention (instrumental delivery). Automated mandatory bolus (AMB) of variable-frequency (VAMB) has been shown to provide better pain relief as compared with conventional patient-controlled epidural analgesia (PCEA) with basal infusion, however its long lockout time per hour is associated with unsuccessful patient bolus requests, with similar motor block to conventional regimens. The investigators therefore proposes to develop a novel epidural delivery regimen: Variable volume AMB (VVAMB) will advance individualisation of labour epidural analgesia, by which a larger volume of bolus may contribute to better spread of the local anaesthetics within brief period and thereby reduces the chances of motor blockade that could reduce instrumental deliveries. This algorithm development including pilot and clinical trial will compare VVAMB with VAMB regimens, in reducing the incidence of motor block in 216 term women requesting for labour epidural analgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Breakthrough Pain
Keywords
Labor Pain, Breakthrough Pain, Infusion pump

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Variable volume Automated Mandatory Bolus (VVAMB)
Arm Type
Experimental
Arm Description
The anaesthetic drug and pain medication are prepared in an epidural infusion pump with the VVAMB programme. The programme uses higher doses with lower frequency of medication (ropivacaine and fentanyl), and a patient control button for the patient to control the additional pain relief demands depending on the requirements during labour.
Arm Title
Automated mandatory bolus (AMB) of variable-frequency (VAMB)
Arm Type
Active Comparator
Arm Description
The anaesthetic drug and pain medication are prepared in an epidural infusion pump with the VAMB programme. The programme uses lower doses with more frequency of medication (ropivacaine and fentanyl), and a patient control button for the patient to control the additional pain relief demands depending on the requirements during labour.
Intervention Type
Device
Intervention Name(s)
Epidural infusion pump
Other Intervention Name(s)
Epidural delivery system
Intervention Description
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Amide local anaesthetic
Intervention Description
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Opioid
Intervention Description
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Primary Outcome Measure Information:
Title
Incidence of motor block in each group
Description
The number of event of motor block throughout the labour. Previous studies have shown that epidural analgesia using high concentrations of local anaesthetics could lead to decreased motor functions, and are subsequently associated with an increased incidence of instrumented delivery and longer second stage of labour. In this study, the intensity of motor block is assessed by the patient's ability to move their lower extremities via a modified Bromage scale. In the modified version, a scoring of 0 implies no motor block (Free movement of both legs and feet), scoring of 1 implies partial block (Just able to flex knees with free movement of feet), 2 implies almost complete block (Unable to flex knees but with free movement of feet) and 3 implies a full block (Unable to move legs/ feet).
Time Frame
During labour (1 day)
Secondary Outcome Measure Information:
Title
Number of subjects with Instrumental delivery
Description
The number of subjects in each group having instrumental delivery (forceps, vacuum delivery)
Time Frame
During labour (1 day)
Title
Number of subjects with Breakthrough pain
Description
The number of subjects in each group having unscheduled epidural supplementation by anaesthetist due to labor pain
Time Frame
During labour (1 day)
Title
APGAR score
Description
The Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score is a test given to newborns soon after birth. In the test, five are being evaluated: Appearance (skin color), Pulse (heart rate), Grimace response (reflexes), Activity (muscle tone) and Respiration (breathing rate and effort). Each is scored on a scale of 0 to 2, with 2 being the best score; a total score of ten represents the best possible condition.
Time Frame
After delivery (1 day)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only females having natural delivery in KKH will be recruited.
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy (American Society of Anesthesiologists (ASA) physical status 1 and 2) primiparous parturient at term (≥36 weeks gestation); Singleton fetus; In early labor stage (cervical dilation ≤5cm); Request labor epidural analgesia and able to administer combined spinal epidural analgesia (CSEA) according to protocol. Exclusion Criteria: Non-cephalic fetal presentation; Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications; Have contraindications to neuraxial blockade or have received parenteral opioids within last 2 hours; Dural puncture/ suspected dural puncture at initiation of CSEA.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ban Leong Sng, FANZCA
Phone
+6563941081
Email
sng.ban.leong@kkh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wan Ling Leong, FANZCA
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan Ling Leong
Email
leong.wan.ling@singhealth.com.sg

12. IPD Sharing Statement

Plan to Share IPD
No

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Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour

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