Postoperative PainNCT03058354
Study to Investigate TIVA With Propofol on Postoperative Pain and Side Effects
An observational study of Postoperative Pain, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Propofol is a commonly used anaesthetic with rapid recovery and less side effects and total intravenous anaesthesia (TIVA) with propofol is a common technique now. The reduction on certain serum pro- inflammatory cytokines may lead to more smooth post- surgical recovery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Propofol and general anaesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing surgery at Queen Mary Hospital, Hong Kong between 2014 to 2016.
Who may be able to join
- Anaesthetic records and acute pain service records of patient undergone surgery between 2014 to 2016 in Queen Mary Hospital would be retrieved from the computer.
Who cannot join
- Essential data were missing.
- Patient participating in other research projects.
- Changes in postoperative pain management technique.
- Patients could not be assessed post-operatively for pain (i.e. post-operative IPPV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study to Investigate Total Intravenous Anaesthesia (TIVA) With Propofol on Postoperative Pain and Side Effects After Surgery
Propofol is a commonly used anaesthetic with rapid recovery and less side effects and total intravenous anaesthesia (TIVA) with propofol is a common technique now. The reduction on certain serum pro- inflammatory cytokines may lead to more smooth post- surgical recovery.
Recent case report proved the analgesic effect of propofol infusion. However other animal and clinical studies showed controversial result.
The aim of this retrospective study is to investigate the postoperative analgesic effects and side effects of intraoperative TIVA with propofol in patient undergoing surgery at Queen Mary Hospital, Hong Kong between 2014 to 2016.
Read the detailed description
Objectives:
- To investigate the analgesic effects of propofol.
- To evaluate the effect of propofol on postoperative adverse events.
Methods:
Retrospective audit.
Data Collection:
- Demographic data;
- Types of analgesic techniques;
- Type of pain relief modalities;
- Pain score up to 72 hours postoperatively;
- Postoperative opioid consumption;
- Incidence of adverse events during APS care;
- Patients' satisfaction on pain relief.
- Conditions
- Postoperative Pain
- Being tested
- Propofol, general anaesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Patient undergoing surgery at Queen Mary Hospital, Hong Kong between 2014 to 2016 using intraoperative TIVA with propofol.
general anaesthesiaProcedure or surgery
Patient undergoing surgery at Queen Mary Hospital, Hong Kong between 2014 to 2016 using general anaesthesia methods other than intraoperative TIVA with propofol.
| Study group | Role | What they receive |
|---|---|---|
| Group TIVA | Patient undergoing surgery at Queen Mary Hospital, Hong Kong between 2014 to 2016 using intraoperative TIVA with propofol. Receives: Drug: Propofol | |
| Group GA | Patient undergoing surgery at Queen Mary Hospital, Hong Kong between 2014 to 2016 using general anaesthesia methods other than intraoperative TIVA with propofol. Receives: Procedure: general anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
pain score using numeral rating scale
Measured: up to postoperative day 3
Secondary outcomes (1)
analgesic consumption
analgesic consumption base on patient drug record
Measured: up to postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start1 Jan 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Sau Ching Stanley, The University of Hong Kong
- Investigators
- Stanley SC Wong, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058354
- Sponsor's protocol ID
- UW17-001
- Status last verified
- Oct 2022
- First submitted
- 7 Feb 2017
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study to Investigate Total Intravenous Anaesthesia (TIVA) With Propofol on Postoperative Pain and Side Effects After Surgery
- ClinicalTrials.gov ID
- NCT03058354
- Acronym / sponsor ID
- UW17-001
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 20 Feb 2017 (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.
Propofol is a commonly used anaesthetic with rapid recovery and less side effects and total intravenous anaesthesia (TIVA) with propofol is a common technique now. The reduction on certain serum pro- inflammatory cytokines may lead to more smooth post- surgical recovery.
Recent case report proved the analgesic effect of propofol infusion. However other animal and clinical studies showed controversial result.
The aim of this retrospective study is to investigate the postoperative analgesic effects and side effects of intraoperative TIVA with propofol in patient undergoing surgery at Queen Mary Hospital, Hong Kong between 2014 to 2016.
Detailed description
Objectives:
- To investigate the analgesic effects of propofol.
- To evaluate the effect of propofol on postoperative adverse events.
Methods:
Retrospective audit.
Data Collection:
- Demographic data;
- Types of analgesic techniques;
- Type of pain relief modalities;
- Pain score up to 72 hours postoperatively;
- Postoperative opioid consumption;
- Incidence of adverse events during APS care;
- Patients' satisfaction on pain relief.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group TIVA | – | Drug: PropofolPatient undergoing surgery at Queen Mary Hospital, Hong Kong between 2014 to 2016 using intraoperative TIVA with propofol. |
| Group GA | – | Procedure: general anaesthesiaPatient undergoing surgery at Queen Mary Hospital, Hong Kong between 2014 to 2016 using general anaesthesia methods other than intraoperative TIVA with propofol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing surgery at Queen Mary Hospital, Hong Kong between 2014 to 2016.
Key inclusion criteria (1 listed)
- Anaesthetic records and acute pain service records of patient undergone surgery between 2014 to 2016 in Queen Mary Hospital would be retrieved from the computer.
Key exclusion criteria (4 listed)
- Essential data were missing.
- Patient participating in other research projects.
- Changes in postoperative pain management technique.
- Patients could not be assessed post-operatively for pain (i.e. post-operative IPPV)
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 |
|---|---|---|
| PropofolPatient undergoing surgery at Queen Mary Hospital, Hong Kong between 2014 to 2016 using intraoperative TIVA with propofol. | Drug | Group TIVA |
| general anaesthesiaPatient undergoing surgery at Queen Mary Hospital, Hong Kong between 2014 to 2016 using general anaesthesia methods other than intraoperative TIVA with propofol. | Procedure or surgery | Group GA |
Primary outcome
pain score
Time frame: up to postoperative day 3
pain score using numeral rating scale
1 secondary outcome
analgesic consumption
Time frame: up to postoperative day 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- 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.
Stanley SC Wong, MBBS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by The University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 13 Oct 2022. 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 Hong Kong. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
pain score (time frame: up to postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2022.