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

NCT04011150 | Recruiting Phase 3

• 1 other identifier: AM/CT001/2018
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain; Breakthrough Pain

Keywords

Labor Pain; Breakthrough Pain; Infusion pump

Outcome Measures

Primary Outcomes (1)

• 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).

  During labour (1 day)

Secondary Outcomes (3)

• Number of subjects with Instrumental delivery

  During labour (1 day)

• Number of subjects with Breakthrough pain

  During labour (1 day)

• APGAR score

  After delivery (1 day)

Study Arms (2)

Variable volume Automated Mandatory Bolus (VVAMB)

EXPERIMENTAL

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.

Device: Epidural infusion pump; Drug: Ropivacaine; Drug: Fentanyl

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

ACTIVE COMPARATOR

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.

Device: Epidural infusion pump; Drug: Ropivacaine; Drug: Fentanyl

Interventions

Epidural infusion pump DEVICE

Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.

Also known as: Epidural delivery system

Automated mandatory bolus (AMB) of variable-frequency (VAMB); Variable volume Automated Mandatory Bolus (VVAMB)

Ropivacaine DRUG

Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.

Also known as: Amide local anaesthetic

Automated mandatory bolus (AMB) of variable-frequency (VAMB); Variable volume Automated Mandatory Bolus (VVAMB)

Fentanyl DRUG

Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.

Also known as: Opioid

Automated mandatory bolus (AMB) of variable-frequency (VAMB); Variable volume Automated Mandatory Bolus (VVAMB)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Gender Eligibility Details: Only females having natural delivery in KKH will be recruited.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

MeSH Terms

Conditions

Labor Pain; Breakthrough Pain

Interventions

Ropivacaine; Fentanyl; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Wan Ling Leong, FANZCA

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ban Leong Sng, FANZCA

CONTACT

+6563941081; sng.ban.leong@kkh.com.sg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 8, 2019
• Study Start: August 11, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)