A Case Series of VPIA Using Remifentanil for Labour and Delivery

Condition(s) targeted: Labor Pain

Intervention: VPIA remifentanil (Device)

Phase: N/A

Status: Recruiting

Sponsored by: KK Women's and Children's Hospital

Official(s) and/or principal investigator(s):
Wan Ling Leong, MBBS FANZCA, Principal Investigator, Affiliation: KK Women's & Children's Hospital

Overall contact:
Wan Ling Leong, MBBS FANZCA, Phone: +65 63941081, Email: leong.wan.ling@kkh.com.sg

This study is a prospective case series aiming to evaluate a new VPIA remifentanil algorithm which would benefit labouring mothers who are unable or unwilling to receive epidural analgesia.

Official title: A Case Series of Vital Signs-controlled, Patient Assisted Intravenous Analgesia (VPIA) Using Remifentanil for Labour and Delivery

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Pain score

Secondary outcome:

Remifentanil drug consumption

Maternal side effects

Maternal outcomes

Detailed description: This study proposes a novel Vital signs-controlled, patient-assisted intravenous analgesia (VPIA) regimen that will enhance the efficacy, safety and personalization of remifentanil therapy for labouring women. This system will study the parturient's pattern of analgesic use in 15 min epochs and titrate the demand doses and basal infusion rate to maintain a plasma level of remifentanil that is appropriate for the degree of pain felt. The system incorporates vital signs (pulse oximetry and heart rate values) into the algorithm which would temporarily stop the pumps and step down doses accordingly when predefined critical values are reached.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Patients who choose to use parenteral opioid for pain relief with informed consent

- Patients who refuse labour epidural analgesia

- Patients with contraindication to epidural analgesia (eg. Thrombocytopaenia, previous

thoraco-lumbar spinal instrumentation) Exclusion Criteria:

- Patients who are unable to understand instructions given regarding the use of patient

controlled analgesia (PCA) or unable to self administer PCA boluses

- Patients with difficulty in communication due to language differences

- Patients with known hypersensitivity to remifentanil or any component of its

formulation or to other fentanyl analogs

- Patients with severe respiratory disease

- Patients with history of drug dependence of recreational drug abuse

- Patients with unmanaged foetal bradycardia

Wan Ling Leong, MBBS FANZCA, Phone: +65 63941081, Email: leong.wan.ling@kkh.com.sg

KK Women's & Children's Hospital, Singapore, Singapore; Recruiting

Starting date: May 2012
Last updated: April 23, 2014