Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551688
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Influence of Preoperative Vitamin D Level on Postoperative Pain in Breast Cancer Surgery Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Influence of Preoperative Vitamin D Level on Postoperative Pain in Breast Cancer Surgery Patients A Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womenVitamin 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 1011121314 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
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 1011121314 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 125 OH2 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 25OHD levels will be measured preoperative Patients will be divided into two groups
1 group D vitamin D-deficient group 30nmolL and 2 group S vitamin D-sufficient group 30nmolL
Randomization
Preoperative serum 25OH 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 11 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 25OHD 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 2mgkg atracurium 05mgkg and fentanyl 1 microgramkg 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 15 volume concentration and IV atracurium 01 mgkg 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 05 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 mgmL with a 20 mg dose a 10 mins lockout interval and a 50 mg 1 hr limit as supplementary analgesia with no background analgesia
Measurement of vitamin D
The characteristics of 25 OH D3 are relatively longer half-life than 125 OH2 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 25OHD levels will be measured preoperative Patients will be divided into two groups
1 group D vitamin D-deficient group 30nmolL and 2 group S vitamin D-sufficient group 30nmolL
Randomization
Preoperative serum 25OH 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 11 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 25OHD 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 2mgkg atracurium 05mgkg and fentanyl 1 microgramkg 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 15 volume concentration and IV atracurium 01 mgkg 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 05 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 mgmL with a 20 mg dose a 10 mins lockout interval and a 50 mg 1 hr limit as supplementary analgesia with no background analgesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None