Influence of Preoperative Vitamin D Level on Postoperative Pain in Breast Cancer Surgery Patients
- Conditions
- Cancer BreastHypovitaminosis D
- Interventions
- Diagnostic Test: Serum 25(OH)D level
- Registration Number
- NCT06551688
- Lead Sponsor
- Fayoum University
- Brief 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 .
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.
- Detailed Description
This study will be performed in the FAYOUM University Hospital after the local Institutional Ethics Committee and local institutional review board approval. Newly diagnosed and pathologically proven breast cancer patients who are prepared for elective breast cancer surgery will be recruited from the general surgery department of our hospital. The study design will be prospective observational study. A detailed informed consent will be signed by the eligible patients before recruitment.
Measurement of vitamin D:
The characteristics of 25 (OH) D3 are relatively longer half-life than 1.25 (OH)2 D3, stability, strong detection repeatability, and no biological activity. Generally, systemic levels of the more stable 25 (OH) D3 are considered to be the best index to reflect status of vitamin D in the individual patient .
study design:
Serum 25(OH)D levels will be measured preoperative . Patients will be divided into two groups :
(1) group D: vitamin D-deficient group (\<30nmol/L); and (2) group S: vitamin D-sufficient group (≥30nmol/L) .
Randomization:
Preoperative serum 25(OH) D levels will be assessed by an anaesthesiologist who will not be included in the study, to get the number of patients required in each group. Randomization will be done via computer-generated random numbers that will be placed in separate closed envelopes and will be opened by study investigators just after induction of general anaesthesia. Neither the patients, the study investigators, the attending clinicians nor the data collectors will be aware of the allocation of groups till the study ends. The patients will be allocated in 1:1 ratio to one of the two groups: group D: vitamin D-deficient group (n= 92 ), and group S: vitamin D-sufficient group (n= 92).
Anaesthesia procedure:
All patients will undergo routine preoperative investigations; CBC, coagulation profile, liver function tests, kidney function tests, ECG and preoperative serum 25(OH)D level. Upon arrival to the operating room, standard monitors (5-lead electrocardiogram, pulse oximeter, noninvasive blood pressure monitoring) will be applied and continue all over the operation. An IV access will be established. All patients will receive IV ondansetron 4 mg before induction of anesthesia as a premedication. General anesthesia will be performed as follows: induction using IV propofol (2mg/kg), atracurium (0.5mg/kg), and fentanyl (1 microgram/kg). A cuffed endotracheal tube (7mm ID) will be placed to secure the airway. Mechanical ventilation parameters will be adjusted to ensure proper oxygenation and ventilation with normocapnia. Maintenance of anesthesia will be made using inhalational anesthesia with isoflurane 1.5% volume concentration and IV atracurium (0.1 mg/kg) every 20 minutes. Continuous hemodynamic monitoring of blood pressure and heart rate will be done . If the systolic blood pressure decreased to a 20% below the baseline or less than 90 mmHg, 5 mg of ephedrine will be injected IV. Moreover, if the heart rate reduced to a 50 bpm or less, 0.5 mg of atropine will be injected IV. At the end of operation , the patients will be transferred to the postoperative anaesthesia care unit for routine monitoring and then to the general surgery department when they have a modified Aldrete score ≥9.
Postoperative Pain Management:
Throughout the first 24 hrs, patients will receive IV paracetamol 1 g every 8 hrs for postoperative analgesia according to the general surgery department protocol.
They also will receive IV tramadol through a patient controlled analgesia (PCA) system (concentration of 4 mg/mL); with; a 20 mg dose, a 10 mins lockout interval and a 50 mg 1 hr limit as supplementary analgesia with no background analgesia.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 184
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description group S Serum 25(OH)D level vitamin D-sufficient group (≥30nmol/L) group D Serum 25(OH)D level vitamin D-deficient group (\<30nmol/L)
- Primary Outcome Measures
Name Time Method Incidence of moderate to severe postoperative pain at 12 hours after surgery Incidence
- Secondary Outcome Measures
Name Time Method Pain assessment by NRS 24 hours before operation during the preoperative visit Pain assessment by numerical rating score (NRS) from 0 to 10 where 0 equals no pain and 10 equals the worst pain
Total fentanyl consumption (in micrograms) intraoperative till end of the operation Pain
Incidence of adverse effects during 1st 24 hours postoperative 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)Heart rate baseline, every 30 minutes up to end of the operation measured in beats per minute
Non- invasive mean arterial blood pressure baseline, every 30 minutes up to end of the operation measured in mmHg
Hospital stay from the date of the operation to the date of discharge from hospital in days (defined as the time elapsed from day 0; the operative day; to the time of discharge)
Postoperative pain scores at times: hour zero, hour 6, hour12, hour18, hour24 postoperative. NRS (Numerical rating scale) (from 0 to 10) ,0 equals no pain and 10 equals the worst pain
American Society of Anaesthesiologists 24 hours before operation 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
Preoperative Serum 25(OH)D level (nmol/L) 24 hours before operation Level
Duration of surgery from start to the end of operation Duration
Total tramadol consumption within 1st 24 hours postoperative measured in mg
Patient satisfaction up to 2 days postoperative will be assessed on a 4-point scale (1: excellent, 2: good 3: fair, 4: poor).
Previous associated comorbidities 24 hours before operation like hypertension, diabetes mellitus, coronary artery disease, chronic renal failure and liver impairment
Trial Locations
- Locations (1)
Fayoum university hospital
🇪🇬Madīnat Al Fayyūm, Faiyum Governorate, Egypt