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Vitamin D Levels and Postoperative Pain in Laparoscopic Cholecystectomy

Sponsor
Bozok University (Other)
Overall Status
Completed
CT.gov ID
NCT04687527
Collaborator
(none)
80
Enrollment
1
Location
11.5
Actual Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Effect of Vitamin D Levels on Postoperative Pain and Narcotic Analgesia in Patients With Laparoscopic Cholecystectomy
    Actual Study Start Date :
    May 15, 2020
    Actual Primary Completion Date :
    Apr 15, 2021
    Actual Study Completion Date :
    Apr 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. preoperative Vitamin D Level and postoperative pain in patients to undergo laparoscopic cholecystectomy operation [6 months]

      Correlations of preoperative Vitamin D Level between postoperative pain in patients undergoing laparoscopic cholecystectomy.to undergo laparoscopic cholecystectomy operation

    Secondary Outcome Measures

    1. preoperative Vitamin D Level and opioid analgesic consumption [6 months]

      Correlations of preoperative Vitamin D Level between opioid analgesic consumption in patients undergoing laparoscopic cholecystectomy.to undergo laparoscopic cholecystectomy operation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bozok University Medical Center Yozgat Turkey

    Sponsors and Collaborators

    • Bozok University

    Investigators

    • Study Chair: Ökkeş Hakan Miniksar, Asist.Prof, YOZGAT BOZOK UNIVERSITY

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ökkeş Hakan Miniksar, Assistant Professor, Bozok University
    ClinicalTrials.gov Identifier:
    NCT04687527
    Other Study ID Numbers:
    • 189_2020.03.25_02
    First Posted:
    Dec 29, 2020
    Last Update Posted:
    Jun 15, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ökkeş Hakan Miniksar, Assistant Professor, Bozok University
    laparoscopic cholecystectomy
    Vitamin D Deficiency
    Postoperative Pain
    Additional relevant MeSH terms:
    Vitamin D Deficiency
    Pain, Postoperative

    Study Results

    No Results Posted as of Jun 15, 2021