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

NCT04011163 | Active Not Recruiting Phase 2

• 1 other identifier: NHIC-I2I-1812002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Respiratory Depression

Keywords

Postoperative pain; Respiratory depression; Bradypnoea; Morphine; Infusion pump

Outcome Measures

Primary Outcomes (1)

• Incidence of a clinically significant bradypnoea

  The number of events of respiratory rate less than 8 per minute throughout the study period (when the patient is connected to the pump)

  Postoperative period (1 - 3 days)

Secondary Outcomes (4)

• Postoperative pain score

  Postoperative period (1 - 3 days)

• Patient satisfaction

  Postoperative period (1 day, after the use of pump)

• Changes in Hospital Anxiety and Depression Scale (HADS) score

  Before surgery (1 day) and postoperative period (1-3 days)

• EQ-5D-3L score

  Before surgery (1 day)

Study Arms (1)

VPIA analgesia

EXPERIMENTAL

VPIA pump will be connected to patients after surgery for up to three days. The vital signs (oxygen saturation, respiratory rate, heart rate) will be closely monitored when patients are using VPIA pump. Intravenous medication (morphine) will be given intravenously.

Device: VPIA pump; Drug: Morphine

Interventions

VPIA pump DEVICE

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.

Also known as: VPIA delivery system

VPIA analgesia

Morphine DRUG

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.

Also known as: Morphine Sulphate

VPIA analgesia

Eligibility Criteria

• Age: 21 Years - 70 Years
• Gender Eligibility Details: Only females undergoing gynecologic surgery in KKH will be recruited.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anaesthesiologist (ASA) physical status I-III;
• Age 21-70 years;
• Receiving patient controlled analgesia of morphine for postoperative analgesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (1)

• Maddox RR, Williams CK, Oglesby H, Butler B, Colclasure B. Clinical experience with patient-controlled analgesia using continuous respiratory monitoring and a smart infusion system. Am J Health Syst Pharm. 2006 Jan 15;63(2):157-64. doi: 10.2146/ajhp050194. No abstract available.

  PMID: 16390930 BACKGROUND

MeSH Terms

Conditions

Pain; Respiratory Insufficiency; Pain, Postoperative; Hypoventilation

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ban Leong Sng, MBBS, MMED

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 8, 2019
• Study Start: March 31, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)