Acute PainNCT02155413
Audit of Tolerability and Safety of Acute Pain Service
An observational study of Acute Pain, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Acute pain service (APS) was introduced in 1990s at Queen Mary Hospital (QMH) as other countries. With accumulation of experience and clinical evidence, APS has been well established. A study conducted in 1997 suggested that monitoring, management protocol and nursing experience were mandatory to the safety for APS. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Pain
- How many people
- 7,500 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2014to Aug 2014
- 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: Postoperative patients who were cared by the Acute Pain Service, Pain Management Team, Department of Anaesthesiology, Queen Mary Hospital between 2009 to 2012.
Who may be able to join
- Postoperative patients who were cared by the Acute Pain Service, Pain Management Team, Department of Anaesthesiology, Queen Mary Hospital between 2009 to 2012.
Who cannot join
- Essential data were missing;
- Patient participating in other research projects.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology, The University of Hong Kong
Hong Kong
Chi Wai Cheung, MD, 852 22553303, cheucw@hku.hk
About this study
Official title: Retrospective Study to Evaluate the Tolerability and Safety of Acute Pain Service at Queen Mary Hospital Between 2009 to 2012
Acute pain service (APS) was introduced in 1990s at Queen Mary Hospital (QMH) as other countries. With accumulation of experience and clinical evidence, APS has been well established. A study conducted in 1997 suggested that monitoring, management protocol and nursing experience were mandatory to the safety for APS. Our recent study showed that pain relief of our post-operative patients using patient controlled analgesic with morphine was still not adequate. The results has driven us to continue the improvement of post-operative outcomes for our surgical patients. Tolerability and safety are always our concerns for patients using our APS. Therefore, the investigators aim to conduct this retrospective study in order to assess if the tolerability and safety of our present APS are adequate or not. The study results will help us to further improve our APS at QMH if necessary.
Read the detailed description
Retrospective audit.
Acute pain service records at Division of Pain Management, Department of Anaesthesiology, Queen Mary Hospital will be identified, validated and analysed.
Data Collection
- Demographic data
- Type of operation
- Type of pain relief modality
- Pain score up to 72 hours postoperatively
- Types of operations and clinical variables
- Incidence of adverse events during APS care;
- Patients safety (ie respiratory depression)
Data Analysis For summarising analysis, mean or median with standard deviation or interquartile range will be reported. Parametric and non-parametric comparative tests will be used for analysis between/among patients with various characteristics. Kaplan Meier survival analysis and log-rank test will be used for duration of APS use.
- Conditions
- Acute Pain
- Keywords
- Acute pain, Audit, Safety, Tolerability
- Medical subject headings
- Acute Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Measured: From postoperative 1 hour to postoperative 72 hour
Secondary outcomes (1)
Incidence of adverse events
Measured: From postoperative 1 hour to postoperative 72 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Time perspective
- Retrospective
- Enrolment
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheung Chi Wai, The University of Hong Kong
- Investigators
- Chi Wai Cheung, MD, Principal investigator, Department of Anaesthesiology, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155413
- Sponsor's protocol ID
- UW14-284
- Status last verified
- Jun 2014
- First submitted
- 2 Jun 2014
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study to Evaluate the Tolerability and Safety of Acute Pain Service at Queen Mary Hospital Between 2009 to 2012
- ClinicalTrials.gov ID
- NCT02155413
- Acronym / sponsor ID
- UW14-284
- Conditions
- Acute Pain
- Keywords
- Acute pain, Audit, Safety, Tolerability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 4 Jun 2014 (estimated)
- 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.
Acute pain service (APS) was introduced in 1990s at Queen Mary Hospital (QMH) as other countries. With accumulation of experience and clinical evidence, APS has been well established. A study conducted in 1997 suggested that monitoring, management protocol and nursing experience were mandatory to the safety for APS. Our recent study showed that pain relief of our post-operative patients using patient controlled analgesic with morphine was still not adequate. The results has driven us to continue the improvement of post-operative outcomes for our surgical patients. Tolerability and safety are always our concerns for patients using our APS. Therefore, the investigators aim to conduct this retrospective study in order to assess if the tolerability and safety of our present APS are adequate or not. The study results will help us to further improve our APS at QMH if necessary.
Detailed description
Retrospective audit.
Acute pain service records at Division of Pain Management, Department of Anaesthesiology, Queen Mary Hospital will be identified, validated and analysed.
Data Collection
- Demographic data
- Type of operation
- Type of pain relief modality
- Pain score up to 72 hours postoperatively
- Types of operations and clinical variables
- Incidence of adverse events during APS care;
- Patients safety (ie respiratory depression)
Data Analysis For summarising analysis, mean or median with standard deviation or interquartile range will be reported. Parametric and non-parametric comparative tests will be used for analysis between/among patients with various characteristics. Kaplan Meier survival analysis and log-rank test will be used for duration of APS use.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postoperative patients who were cared by the Acute Pain Service, Pain Management Team, Department of Anaesthesiology, Queen Mary Hospital between 2009 to 2012.
Key inclusion criteria (1 listed)
- Postoperative patients who were cared by the Acute Pain Service, Pain Management Team, Department of Anaesthesiology, Queen Mary Hospital between 2009 to 2012.
Key exclusion criteria (2 listed)
- Essential data were missing;
- Patient participating in other research projects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain score
Time frame: From postoperative 1 hour to postoperative 72 hour
1 secondary outcome
Incidence of adverse events
Time frame: From postoperative 1 hour to postoperative 72 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
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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.
Chi Wai Cheung, MD principal investigator
Department of Anaesthesiology, 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 Acute 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 2 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: status not confirmed, as of the sponsor's last update on 4 Jun 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi Wai Cheung, MD (852 22553303, cheucw@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: From postoperative 1 hour to postoperative 72 hour). 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 4 Jun 2014.