Suspended

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

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What is being tested

VPIA pump

+ Morphine

DeviceDrug
Who is being recruted

Hypoventilation+9

+ Neurologic Manifestations

+ Pain

From 21 to 70 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: March 2021
See protocol details

Summary

Principal SponsorKK Women's and Children's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 31, 2021

Actual date on which the first participant was enrolled.

The investigators will conduct a prospective cohort study in 150 adult female subjects that undergo major surgery that require postoperative patient controlled morphine analgesia so as to examine the monitoring performance of oxygen desaturation, respiratory depression and patient satisfaction and user feedback. Patients who are undergoing elective surgery with plan to use postoperative patient controlled analgesia with morphine will receive study information either at pre-operative assessment clinic or upon admission for surgery if they have not attended the pre-operative assessment clinic. They will be screened for eligibility using the inclusion and exclusion criteria. If eligible for recruitment, the patients will be approached by the investigators for recruitment. Upon successful recruitment of the study, patients will be asked to complete two questionnaires and rate their pre-surgical pain on the numerical rating scale in the pre-anaesthetic evaluation clinic. The general anaesthesia technique and type of analgesia administered intra-operatively will be according to standard practice and is at the discretion of the attending anaesthesiologist. After surgery, patients will be reviewed daily (up to 3 days) in the post-operative wards. They will be asked on questionnaire scoring, pain score, and analgesia information and adverse event, if any.

Official TitleVital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical Pain
NCT04011163
Principal SponsorKK Women's and Children's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 21 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HypoventilationNeurologic ManifestationsPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsRespiration DisordersRespiratory InsufficiencyRespiratory Tract DiseasesSigns and SymptomsSigns and Symptoms, RespiratoryPathological Conditions, Signs and Symptoms

Criteria

3 inclusion criteria required to participate
American Society of Anaesthesiologist (ASA) physical status I-III;

Age 21-70 years;

Receiving patient controlled analgesia of morphine for postoperative analgesia.

5 exclusion criteria prevent from participating
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;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

KK Women's and Children's Hospital

Singapore, SingaporeOpen KK Women's and Children's Hospital in Google Maps
SuspendedOne Study Center
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