Influence of Preoperative Vitamin D Level on Postoperative Pain in Breast Cancer Surgery Patients
NCT Number: NCT06551688
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cancer Breast|Hypovitaminosis D
Interventions: DIAGNOSTIC_TEST: Serum 25(OH)D level
Sponsor: Fayoum University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 184
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-12-30
Locations: Fayoum university hospital, Madīnat Al Fayyūm, Faiyum Governorate, 63514, Egypt

Summary:
Vitamin D deficiency is a general problem that vigorously affects human health . Breast cancer is the most frequently diagnosed life-threatening cancer in women and the leading cause of cancer death among women.Vitamin D deficiency is common in breast cancer patients and some evidence suggests that low vitamin D status enhances the risk for disease development or progression .

Though the relationship between vitamin D and breast cancer is unclear . Several research studies currently support vitamin D deficiency as a risk factor for breast cancer. Observational studies have also revealed significant relationships of vitamin D with breast cancer, colorectal cancer, prostate cancer and pancreatic cancer 10'11'12'13'14. However, no work has been done to investigate the relationship between vitamin D deficiency and acute postoperative pain in breast cancer surgery patients. In the current study we will investigate the relationship between preoperative vitamin D levels and acute postoperative pain in cancer breast surgery patients.

The aim of current study is to investigate the relationship between preoperative vitamin D levels and acute postoperative pain in breast cancer surgery patients.

Primary Outcome Measures: Incidence of moderate to severe postoperative pain, Incidence, at 12 hours after surgery
Secondary Outcome Measures: American Society of Anaesthesiologists, The ASA Classification is a physical status classification used to determine a patient's risk with anaesthesia1. The classification runs from ASA I to ASA VI, with the higher the number indicating a greater risk, 24 hours before operation|Pain assessment by NRS, Pain assessment by numerical rating score (NRS) from 0 to 10 where 0 equals no pain and 10 equals the worst pain, 24 hours before operation during the preoperative visit|Previous associated comorbidities, like hypertension, diabetes mellitus, coronary artery disease, chronic renal failure and liver impairment, 24 hours before operation|Preoperative Serum 25(OH)D level (nmol/L), Level, 24 hours before operation|Duration of surgery, Duration, from start to the end of operation|Total fentanyl consumption (in micrograms), Pain, intraoperative till end of the operation|Heart rate, measured in beats per minute, baseline, every 30 minutes up to end of the operation|Non- invasive mean arterial blood pressure, measured in mmHg, baseline, every 30 minutes up to end of the operation|Postoperative pain scores, NRS (Numerical rating scale) (from 0 to 10) ,0 equals no pain and 10 equals the worst pain, at times: hour zero, hour 6, hour12, hour18, hour24 postoperative.|Total tramadol consumption, measured in mg, within 1st 24 hours postoperative|Incidence of adverse effects, nausea and vomiting (0 = no symptoms, 1 = only nausea, 2 = nausea and vomiting), respiratory depression (respiratory rate less than 10), sedation (0 = awake and alert,

1 = quietly awake, 2 = asleep but easily arousable, 3 = deep sleep, responding to painful stimulus), during 1st 24 hours postoperative|Hospital stay, in days (defined as the time elapsed from day 0; the operative day; to the time of discharge), from the date of the operation to the date of discharge from hospital|Patient satisfaction, will be assessed on a 4-point scale (1: excellent, 2: good 3: fair, 4: poor)., up to 2 days postoperative