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

Labor Pain Clinical Trial

Official title: Development of Variable Volume Automated Mandatory Boluses (VVAMB) for Patient-controlled Epidural Analgesia During Labour and Delivery

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breakthrough Pain
• Labor Pain

• NCT number: NCT04011150
• Study type: Interventional
• Source: KK Women's and Children's Hospital
• Contact: Ban Leong Sng, FANZCA
• Phone: +6563941081
• Email: sng.ban.leong@kkh.com.sg
• Status: Recruiting
• Phase: Phase 3
• Start date: August 11, 2020
• Completion date: August 31, 2025