Cholecystitis, AcuteNCT03021447
Prediction of Postoperative Pain by Injection Pain of Propofol
An observational study of Cholecystitis, Acute, run by Ajou University School of Medicine.
Trial summary
Postoperative pain is a significant postoperative problem and it could be persistent if proper management is not provided. However, each patient shows different intensity of pain and different sensitivity to analgesics even if they underwent same procedures. Read more about this study
- Who is it for?
- Ages 19 to 60 years, women only
- Conditions the study is for
- Cholecystitis, Acute
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2017
- 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 19 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients scheduled for laparoscopic cholecystectomy will be included.
Who may be able to join
- America Society of Anesthesiologists class I-II
- Laparoscopic cholecystectomy
Who cannot join
- Pregnancy
- Illiteracy
About this study
Postoperative pain is a significant postoperative problem and it could be persistent if proper management is not provided. However, each patient shows different intensity of pain and different sensitivity to analgesics even if they underwent same procedures. Therefore, it would be useful to find the way to predict the postoperative pain sensitivity.
Propofol, a popular anesthetic agent, induces pain during injection, which can not completely prevented by opioid or lidocaine in some patients. This is considered to be related to patient's pain sensitivity and it might be associated with postoperative pain sensitivity.
Therefore, the relation of propofol injection pain and postoperative pain intensity will be explored.
- Conditions
- Cholecystitis, Acute
- Medical subject headings
- Cholecystitis, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain intensity_1
Postoperative pain will be evaluated with verbal numeric scale (0-10)
Measured: 10 min after postanesthesia care unit admission
Secondary outcomes (6)
postoperative pain intensity_2
Postoperative pain will be evaluated with verbal numeric scale (0-10)
Measured: 20 min after postanesthesia care unit admission
postoperative pain intensity_3
Postoperative pain will be evaluated with verbal numeric scale (0-10)
Measured: 30 min after postanesthesia care unit admission
postoperative pain intensity_4
Postoperative pain will be evaluated with verbal numeric scale (0-10)
Measured: 4 hours after operation
postoperative pain intensity_8
Postoperative pain will be evaluated with verbal numeric scale (0-10)
Measured: 8 hours after operation
postoperative pain intensity_12
Postoperative pain will be evaluated with verbal numeric scale (0-10)
Measured: 12 hours after operation
postoperative pain intensity_24
Postoperative pain will be evaluated with verbal numeric scale (0-10)
Measured: 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis, AcuteStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Go Un Roh, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021447
- Sponsor's protocol ID
- AJIRB-MED-OBS-16-48
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2017
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Postoperative Pain by Injection Pain of Propofol
- ClinicalTrials.gov ID
- NCT03021447
- Acronym / sponsor ID
- AJIRB-MED-OBS-16-48
- Conditions
- Cholecystitis, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Jan 2017 (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.
Postoperative pain is a significant postoperative problem and it could be persistent if proper management is not provided. However, each patient shows different intensity of pain and different sensitivity to analgesics even if they underwent same procedures. Therefore, it would be useful to find the way to predict the postoperative pain sensitivity.
Propofol, a popular anesthetic agent, induces pain during injection, which can not completely prevented by opioid or lidocaine in some patients. This is considered to be related to patient's pain sensitivity and it might be associated with postoperative pain sensitivity.
Therefore, the relation of propofol injection pain and postoperative pain intensity will be explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients scheduled for laparoscopic cholecystectomy will be included.
Key inclusion criteria (2 listed)
- America Society of Anesthesiologists class I-II
- Laparoscopic cholecystectomy
Key exclusion criteria (2 listed)
- Pregnancy
- Illiteracy
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 intensity_1
Time frame: 10 min after postanesthesia care unit admission
Postoperative pain will be evaluated with verbal numeric scale (0-10)
6 secondary outcomes
postoperative pain intensity_2
Time frame: 20 min after postanesthesia care unit admission
postoperative pain intensity_3
Time frame: 30 min after postanesthesia care unit admission
postoperative pain intensity_4
Time frame: 4 hours after operation
postoperative pain intensity_8
Time frame: 8 hours after operation
postoperative pain intensity_12
Time frame: 12 hours after operation
postoperative pain intensity_24
Time frame: 24 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis, Acute, run by Ajou University School of Medicine.
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 2 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 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
postoperative pain intensity_1 (time frame: 10 min after postanesthesia care unit admission). 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 16 Jan 2017.