Vitamin D Levels and Postoperative Pain in Laparoscopic Cholecystectomy

June 13, 2021 updated by: Ökkeş Hakan Miniksar, Bozok University

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.

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Yozgat, Turkey
        • Bozok University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Volunteer patients undergoing elective laparoscopic cholecystectomy surgery by the Department of General Surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preoperative Vitamin D Level and opioid analgesic consumption
Time Frame: 6 months
Correlations of preoperative Vitamin D Level between opioid analgesic consumption in patients undergoing laparoscopic cholecystectomy.to undergo laparoscopic cholecystectomy operation
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bozok University

Investigators

  • Study Chair: Ökkeş Hakan Miniksar, Asist.Prof, Yozgat Bozok University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2020

Primary Completion (Actual)

April 15, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

December 24, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Actual)

June 15, 2021

Last Update Submitted That Met QC Criteria

June 13, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 189_2020.03.25_02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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