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Clinical trial

Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical Pain

ID
Name
NHIC-I2I-1812002
Description
To meet the unmet need of better and safer pain relief for acute pain in the post-operative setting, a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia ("VPIA") Delivery System, with novel and intelligent software algorithms and specialised hardware was developed. In the previous project, the investigators have shown that this system has the potential to increase the safety and patient satisfaction with intravenous opioid analgesia. However, opportunities to develop more robust vital signs monitoring with the goal of ensuring continual and effective analgesia are identified. The primary aim of this proposal is to advance the development of technology (through new features and functionality) and perform clinical evaluation of the VPIA system with a larger sample size to show improvements in patient's satisfaction (pain relief) and robustness of system in terms of vital signs integration. Novel technology using adaptive vital signs controller, integrated with an infusion pump and single finger probe vital signs monitor system will be developed with the aim for commercialisation.
Trial arms
Trial start
2021-03-31
Estimated PCD
2023-12-31
Trial end
2025-12-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
VPIA pump
The pump is a specially designed and manufactured infusion syringe pump for intravenous analgesia. It incorporates the VPIA study regimen to meet the specific requirements of the clinical trial. It is intended to be used only for delivering drugs intravenously.
Arms:
VPIA analgesia
Other names:
VPIA delivery system
Morphine
Intravenous medication used is morphine diluted in normal saline to a concentration of 1mg/ml. This is a standard dilution and are routine drugs used as standard of care.
Arms:
VPIA analgesia
Other names:
Morphine Sulphate
Size
40
Primary endpoint
Incidence of a clinically significant bradypnoea
Postoperative period (1 - 3 days)
Eligibility criteria
Inclusion Criteria: * American Society of Anaesthesiologist (ASA) physical status I-III; * Age 21-70 years; * Receiving patient controlled analgesia of morphine for postoperative analgesia. Exclusion Criteria: * Allergy to study drug; * With significant respiratory disease and obstructive sleep apnea; * Unwilling to place oxygen saturation and respiratory rate monitoring during study period; * Unable to comprehend the use of patient controlled analgesia; * Obstetric patients.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-10-04

1 organization

1 product

2 indications

Organization
KK Women's and Children's Hospital
Product
Morphine
Indication
Pain
Indication
Respiratory Depression