Vitamin D DeficiencyNCT04687527
Vitamin D Levels and Postoperative Pain in Laparoscopic Cholecystectomy
An observational study of Vitamin D Deficiency and Postoperative Pain, run by Bozok University at 1 site in Turkey (Türkiye).
Trial summary
The deficiency of vitamin D is common in patients with gastrointestinal system disorders. Vitamin D has been associated with chronic non-specific musculoskeletal pain and migraines due to anti-inflammatory effects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Postoperative Pain
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2020to 30 Apr 2021
- How long will I take part?
- 6 Months
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteer patients undergoing elective laparoscopic cholecystectomy surgery by the Department of General Surgery
Who may be able to join
- Volunteer,
- Between the Ages Of 18-65,
- Least Primary School Graduate,
- Not Using Drugs That May Affect Cognitive Functions,
- Non-Alcohol Substance Use,
- Patients Without Psychiatric and Neurological Disease.
Who cannot join
- Those with known psychiatric disease and drugs,
- Those with an important cardiovascular or central nervous system disease,
- Patients with pain syndromes or routinely using opioid.
- Very urgent patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vitamin D Levels on Postoperative Pain and Narcotic Analgesia in Patients With Laparoscopic Cholecystectomy
The deficiency of vitamin D is common in patients with gastrointestinal system disorders.
Vitamin D has been associated with chronic non-specific musculoskeletal pain and migraines due to anti-inflammatory effects.
Read more
This prospective observational study will undergo elective laparoscopic cholecystectomy surgery between 18 and 65 years, is planned to participate in ASA (American Society of Anesthesiologists) 1-3, 90 volunteer patients.
In preoperative evaluation, the remaining 3 ml of blood was centrifuged from the routine received blood to determine the level of vitamin D will be kept.
Postoperative will be applied to patient controlled analgesia to all patients for 24 hours.
To determine the level of postoperative pain, the visual analog scale (VAS) will be used in the clock unit and at the service 6, 12 and 24 hours.
In this study, the investigators aimed to test the hypothesis of relation to pain and opioid consumption in acute postoperative (24 hours) of perioperative low-vitamin D.
- Conditions
- Vitamin D Deficiency, Postoperative Pain
- Keywords
- laparoscopic cholecystectomy, Vitamin D Deficiency, Postoperative Pain
- Medical subject headings
- Vitamin D Deficiency, Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative Vitamin D Level and postoperative pain in patients to undergo laparoscopic cholecystectomy operation
Correlations of preoperative Vitamin D Level between postoperative pain in patients undergoing laparoscopic cholecystectomy.to undergo laparoscopic cholecystectomy operation
Measured: 6 months
Secondary outcomes (1)
preoperative Vitamin D Level and opioid analgesic consumption
Correlations of preoperative Vitamin D Level between opioid analgesic consumption in patients undergoing laparoscopic cholecystectomy.to undergo laparoscopic cholecystectomy operation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start15 May 2020
- Primary completion15 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ökkeş Hakan Miniksar, Bozok University
- Investigators
- Ökkeş Hakan Miniksar, Asist.Prof, Study chair, Yozgat Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687527
- Sponsor's protocol ID
- 189_2020.03.25_02
- Status last verified
- Jun 2021
- First submitted
- 22 Dec 2020
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Levels on Postoperative Pain and Narcotic Analgesia in Patients With Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04687527
- Acronym / sponsor ID
- 189_2020.03.25_02
- Conditions
- Vitamin D Deficiency, Postoperative Pain
- Keywords
- laparoscopic cholecystectomy, Vitamin D Deficiency, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 29 Dec 2020 (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.
The deficiency of vitamin D is common in patients with gastrointestinal system disorders.
Vitamin D has been associated with chronic non-specific musculoskeletal pain and migraines due to anti-inflammatory effects.
This prospective observational study will undergo elective laparoscopic cholecystectomy surgery between 18 and 65 years, is planned to participate in ASA (American Society of Anesthesiologists) 1-3, 90 volunteer patients.
In preoperative evaluation, the remaining 3 ml of blood was centrifuged from the routine received blood to determine the level of vitamin D will be kept.
Postoperative will be applied to patient controlled analgesia to all patients for 24 hours.
To determine the level of postoperative pain, the visual analog scale (VAS) will be used in the clock unit and at the service 6, 12 and 24 hours.
In this study, the investigators aimed to test the hypothesis of relation to pain and opioid consumption in acute postoperative (24 hours) of perioperative low-vitamin D.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteer patients undergoing elective laparoscopic cholecystectomy surgery by the Department of General Surgery
Key inclusion criteria (6 listed)
- Volunteer,
- Between the Ages Of 18-65,
- Least Primary School Graduate,
- Not Using Drugs That May Affect Cognitive Functions,
- Non-Alcohol Substance Use,
Key exclusion criteria (4 listed)
- Those with known psychiatric disease and drugs,
- Those with an important cardiovascular or central nervous system disease,
- Patients with pain syndromes or routinely using opioid.
- Very urgent patients
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
preoperative Vitamin D Level and postoperative pain in patients to undergo laparoscopic cholecystectomy operation
Time frame: 6 months
Correlations of preoperative Vitamin D Level between postoperative pain in patients undergoing laparoscopic cholecystectomy.to undergo laparoscopic cholecystectomy operation
1 secondary outcome
preoperative Vitamin D Level and opioid analgesic consumption
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Ökkeş Hakan Miniksar, Asist.Prof study chair
Yozgat Bozok University
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 Vitamin D Deficiency and Postoperative Pain, run by Bozok University at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 15 Jun 2021. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
preoperative Vitamin D Level and postoperative pain in patients to undergo laparoscopic cholecystectomy operation (time frame: 6 months). 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 15 Jun 2021.