Vitamin D Levels and Postoperative Pain in Laparoscopic Cholecystectomy

NCT04687527 | Completed

• 1 other identifier: 189_2020.03.25_02
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Postoperative Pain

Keywords

laparoscopic cholecystectomy; Vitamin D Deficiency; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (1)

• preoperative Vitamin D Level and opioid analgesic consumption

  6 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozok University: lead

Study Sites (1)

Bozok University Medical Center

Yozgat, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Pain, Postoperative

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ökkeş Hakan Miniksar, Asist.Prof

  YOZGAT BOZOK UNIVERSITY

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 29, 2020
• Study Start: May 15, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 30, 2021
• Last Updated: June 15, 2021

Record last verified: 2021-06

Locations

TU (1)