Pain / Respiratory Depression / Morphine · Phase 2/3 Trial

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

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered Phase 2/3 clinical trial of a vital-signs-integrated patient-controlled intravenous opioid analgesia (VPIA) pump with integrated morphine delivery and vital signs monitoring. The trial enrolled 40 participants to evaluate safety (incidence of clinically significant bradypnoea) and efficacy (patient satisfaction with pain relief) in the postoperative period; no results are reported in this registry entry.

What was studied

Phase 2/3, Interventional, Single Group, Open label, Treatment purpose. Pain, Respiratory Depression; Female; age from 21 Years; to 70 Years. Intervention: VPIA analgesia. n = 40. 1 site: Singapore.

Key findings

Safety

Primary and secondary outcome results, adverse events, and patient satisfaction scores are not available.

Who this may help

If completed and published, this trial may inform whether vital-signs-integrated patient-controlled morphine delivery reduces respiratory depression risk while maintaining analgesia satisfaction compared to standard postoperative opioid regimens. Clinical relevance depends on results and comparison arm definition, neither reported here.

Plain-language summary

This is an active clinical trial registry record with no reported results; enrollment is complete at 40 participants but outcomes have not been published in this registry entry.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Incidence of a clinically significant bradypnoea (assessed at Postoperative period (1 - 3 days))

DesignPhase 2/3, Interventional, Single Group, Open label, Treatment purpose

PopulationPain, Respiratory Depression; Female; age from 21 Years; to 70 Years

Sample size40

InterventionVPIA analgesia

Setting1 site: Singapore

Reported figures

Quoted from the source exactly as published.

Sample size40

PhasePhase 2/3

Primary outcome measureIncidence of a clinically significant bradypnoea, postoperative period (1–3 days)

Recruitment statusActive, not recruiting

Clinical bottom line

Caveats

No results or outcome data reported in this registry record.
Comparator arm not specified in registry entry; cannot assess whether trial is superiority, non-inferiority, or single-arm.
Enrollment actually 40; unclear whether this represents final target or interim reporting.
Primary and secondary outcome results, adverse events, and patient satisfaction scores are not available.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2/3 interventional study; design details (randomization, blinding) not specified in registry.

Directness

moderate

Directly addresses postoperative pain safety and analgesia; primary outcome is bradypnoea incidence.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record.

Risk of bias

insufficient

Registry record does not describe randomization, allocation concealment, or blinding methods.

Sample adequacy

limited

Actual enrollment 40 participants; modest sample for Phase 2/3 claim.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04011163). This is a study registration, not published results. Lead sponsor: KK Women's and Children's Hospital. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 40 participants (ACTUAL). Conditions: Pain, Respiratory Depression. Interventions: DEVICE: VPIA pump; DRUG: Morphine. Primary outcome measures: Incidence of a clinically significant bradypnoea , Postoperative period (1 - 3 days). 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT04011163PainRespiratory DepressionKK Women's and Children's HospitalMorphineVPIA pump