Acute Post Operative PainNCT05624502
Improvement in Postoperative Pain Outcomes
An observational study of Acute Post Operative Pain, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
This is an observational study project aims at improving postoperative pain outcomes by evaluating the current status of postoperative pain managements in the institution. Then the investigators will compare the results by internal and external benchmarking. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Post Operative Pain
- How many people
- 1,000 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2019to 31 Dec 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute postoperative pain patients after different surgical procedures
Who may be able to join
- Postoperative patients during the first 24 hours of surgery (day 1)
- Male and Females
- Adults
Who cannot join
- Patient refusal
- Drug abusers and addicts
- Major significant systemic diseases
- Language barriers
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Salah N. El-Tallawy
Riyadh, 7805
SALAH N. N. EL-TALLAWY, 0114692191, salaheltallawy@yahoo.com
About this study
Official title: Mprovement in Postoperative Pain Outcome: Pain Registry
This is an observational study project aims at improving postoperative pain outcomes by evaluating the current status of postoperative pain managements in the institution. Then the investigators will compare the results by internal and external benchmarking. Then they will suggest recommendations to improve the current situation of postoperative pain management.
Read the detailed description
At least half of the patients suffer from moderate to severe post-operative pain. The price of poorly managed pain is high: pain impedes recovery, causes suffering and prolongs the hospital stay. PAIN OUT provides tools for measurement, feedback and benchmarking of pain treatment quality in order to improve patient care. A research project that aims at improving postoperative pain treatment outcomes by evaluating the current status of postoperative pain managements in our institution. Then the investigators compare the results by internal and external benchmarking. Then suggest recommendations to improve the current situation of postoperative pain management.
parameters include" Patient's data Pain assessments by using the visual analogue score of 11 point (from "0" no pain - "10" worst pain) will be evaluated as the following: Worst pain since surgery, Least pain since surgery, Pain score at rest. Pain score during movements in bed, Pain score during deep breathing and coughing, How often the severe pain since surgery (%), Does the pain interfere with sleeping pattern, and the side effects.
- Conditions
- Acute Post Operative Pain
- Keywords
- acute postoperative pain, orthopedic surgery, general surgery, obs/gyn surgery, Neurosurgery, Bariatric surgery, Thoracic surgery, opioids, NSAIDs, Regional analgesia
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain scores
using visual analogue scale (VAS) for pain assessment of 11 points (from "0" no pain to "10" worst pain
Measured: first 3 days postoperative
time in severe pain
duration of time spent in severe pain after surgery
Measured: during the first 24 hours
dynamic and static pain
Pain scores or rest and during movements
Measured: during the first 24 hours
Secondary outcomes (3)
worst and least pain
The highest and lowest pain scores during the first 24 hours
Measured: during the first 24 hours
time to first request of analgesia
the time from the recovery to the first request of postoperative analgesia
Measured: during the first 24 hours
total analgesic consumption
total consumption of opioids / non-opioids during the first 24 hours
Measured: during the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start1 Jan 2019
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Post Operative PainStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SALAH EL-TALLAWY, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624502
- Sponsor's protocol ID
- 18/0443/IRB
- Status last verified
- Dec 2022
- First submitted
- 13 Nov 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mprovement in Postoperative Pain Outcome: Pain Registry
- ClinicalTrials.gov ID
- NCT05624502
- Acronym / sponsor ID
- 18/0443/IRB
- Conditions
- Acute Post Operative Pain
- Keywords
- acute postoperative pain, orthopedic surgery, general surgery, obs/gyn surgery, Neurosurgery, Bariatric surgery, Thoracic surgery, opioids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Nov 2022 (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.
This is an observational study project aims at improving postoperative pain outcomes by evaluating the current status of postoperative pain managements in the institution. Then the investigators will compare the results by internal and external benchmarking. Then they will suggest recommendations to improve the current situation of postoperative pain management.
Detailed description
At least half of the patients suffer from moderate to severe post-operative pain. The price of poorly managed pain is high: pain impedes recovery, causes suffering and prolongs the hospital stay. PAIN OUT provides tools for measurement, feedback and benchmarking of pain treatment quality in order to improve patient care. A research project that aims at improving postoperative pain treatment outcomes by evaluating the current status of postoperative pain managements in our institution. Then the investigators compare the results by internal and external benchmarking. Then suggest recommendations to improve the current situation of postoperative pain management.
parameters include" Patient's data Pain assessments by using the visual analogue score of 11 point (from "0" no pain - "10" worst pain) will be evaluated as the following: Worst pain since surgery, Least pain since surgery, Pain score at rest. Pain score during movements in bed, Pain score during deep breathing and coughing, How often the severe pain since surgery (%), Does the pain interfere with sleeping pattern, and the side effects.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute postoperative pain patients after different surgical procedures
Key inclusion criteria (3 listed)
- Postoperative patients during the first 24 hours of surgery (day 1)
- Male and Females
- Adults
Key exclusion criteria (4 listed)
- Patient refusal
- Drug abusers and addicts
- Major significant systemic diseases
- Language barriers
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
postoperative pain scores
Time frame: first 3 days postoperative
using visual analogue scale (VAS) for pain assessment of 11 points (from "0" no pain to "10" worst pain
time in severe pain
Time frame: during the first 24 hours
duration of time spent in severe pain after surgery
dynamic and static pain
Time frame: during the first 24 hours
Pain scores or rest and during movements
3 secondary outcomes
worst and least pain
Time frame: during the first 24 hours
time to first request of analgesia
Time frame: during the first 24 hours
total analgesic consumption
Time frame: during the first 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 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.
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 Post Operative Pain, run by King Saud University at 1 site in Saudi Arabia.
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 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: status not confirmed, as of the sponsor's last update on 27 Dec 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 Saudi Arabia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain scores (time frame: first 3 days postoperative). The study lists 3 primary outcomes in all. 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 27 Dec 2022.