PainPhase 2/3VPIANCT04011163
Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical Pain
A Phase 2/3 study testing VPIA pump and Morphine in people with Pain and Respiratory Depression, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Pain, Respiratory Depression
- What is being tested?
- VPIA pump and Morphine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 31 Mar 2021to 31 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anaesthesiologist (ASA) physical status I-III;
- Age 21-70 years;
- Receiving patient controlled analgesia of morphine for postoperative analgesia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Pain, Respiratory Depression
- Being tested
- VPIA pump, Morphine
- Keywords
- Postoperative pain, Respiratory depression, Bradypnoea, Morphine, Infusion pump
- Medical subject headings
- Pain, Respiratory Insufficiency, Pain, Postoperative, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPIA pumpDevice
Also called VPIA delivery system
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.
MorphineDrug
Also called Morphine Sulphate
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: VPIA pump; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Postoperative period (1 - 3 days)
Secondary outcomes (4)
Postoperative pain score
Pain scores (Numeric Rating Scale 0-10) will be asked, with zero being no pain, and 10 being the worst pain possible.
Measured: Postoperative period (1 - 3 days)
Patient satisfaction
Patient will be asked about their satisfaction level on the pump based on ordinal scale (Strongly disagree, disagree, neutral, agree, strongly agree).
Measured: Postoperative period (1 day, after the use of pump)
Changes in Hospital Anxiety and Depression Scale (HADS) score
HADS Anxiety and Depression score before and after surgery. HADS is commonly used by doctors to determine the levels of anxiety and depression that a patient is experiencing. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. For each subscore (anxiety/depression), 0-7 = Normal; 8-10 = Borderline abnormal (borderline case); and 11-21 = Abnormal (case).
Measured: Before surgery (1 day) and postoperative period (1-3 days)
EQ-5D-3L score
EQ-5D-3L score before surgery. EQ-5D-3L is a standardized instrument for measuring generic health status. It is made up for two components; health state description and evaluation. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-3. From these five dimensions, EQ-5D index is calculated, having a value between 0-1. The evaluation part involves an analogue scale, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to " the worst health you can imagine", and hundred corresponds to "the best health you can imagine".
Measured: Before surgery (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start31 Mar 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
- Investigators
- Ban Leong Sng, MBBS, MMED, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011163
- Sponsor's protocol ID
- NHIC-I2I-1812002
- Acronym
- VPIA
- Status last verified
- Aug 2026
- First submitted
- 4 Jul 2019
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16390930
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical Pain
- ClinicalTrials.gov ID
- NCT04011163
- Acronym / sponsor ID
- VPIA / NHIC-I2I-1812002
- Conditions
- Pain, Respiratory Depression
- Keywords
- Postoperative pain, Respiratory depression, Bradypnoea, Morphine, Infusion pump
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VPIA analgesia | Experimental | Device: VPIA pump, Drug: MorphineVPIA 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anaesthesiologist (ASA) physical status I-III;
- Age 21-70 years;
- Receiving patient controlled analgesia of morphine for postoperative analgesia.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VPIA pumpAlso: VPIA delivery systemThe 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. | Device | VPIA analgesia |
| MorphineAlso: Morphine SulphateIntravenous 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. | Drug | VPIA analgesia |
Primary outcome
Incidence of a clinically significant bradypnoea
Time frame: Postoperative period (1 - 3 days)
The number of events of respiratory rate less than 8 per minute throughout the study period (when the patient is connected to the pump)
4 secondary outcomes
Postoperative pain score
Time frame: Postoperative period (1 - 3 days)
Patient satisfaction
Time frame: Postoperative period (1 day, after the use of pump)
Changes in Hospital Anxiety and Depression Scale (HADS) score
Time frame: Before surgery (1 day) and postoperative period (1-3 days)
EQ-5D-3L score
Time frame: Before surgery (1 day)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 16390930Maddox 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ban Leong Sng, MBBS, MMED principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing VPIA pump and Morphine in people with Pain and Respiratory Depression, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of a clinically significant bradypnoea (time frame: Postoperative period (1 - 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04011163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.