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

Labor Pain Clinical Trial

— VVAMB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04011150
• Other study ID #: AM/CT001/2018
• Status: Recruiting
• Phase: Phase 3
• Start date: August 11, 2020
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2023
• Source: KK Women's and Children's Hospital
• Contact: Ban Leong Sng, FANZCA
• Phone: +6563941081
• Email: sng.ban.leong[@]kkh.com.sg
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: August 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breakthrough Pain
• Labor Pain

Intervention

Device:
• Epidural infusion pump
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.
• 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.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of subjects with Instrumental delivery	The number of subjects in each group having instrumental delivery (forceps, vacuum delivery)	During labour (1 day)
Secondary	Number of subjects with Breakthrough pain	The number of subjects in each group having unscheduled epidural supplementation by anaesthetist due to labor pain	During labour (1 day)
Secondary	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.	After delivery (1 day)