Influence of Preoperative Vitamin D Level on Postoperative Pain in Breast Cancer Surgery Patients
NCT ID: NCT06551688
Last Updated: 2025-05-06
Study Results
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Basic Information
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COMPLETED
184 participants
OBSERVATIONAL
2024-09-01
2025-04-20
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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group D
vitamin D-deficient group (\<30nmol/L)
Serum 25(OH)D level
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
group S
vitamin D-sufficient group (≥30nmol/L)
Serum 25(OH)D level
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
Interventions
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Serum 25(OH)D level
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
Eligibility Criteria
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Inclusion Criteria
* aged 20-65 years, who will be scheduled to undergo elective unilateral breast cancer surgery.
* modified radical mastectomy.
Exclusion Criteria
* Chronic opioid use.
* cognitive disorders.
* patients using drugs affecting the levels of calcium, phosphorus, and vitamin D, such as vitamin D supplement, calcitonin, and estrogen or its analogs, one month before enrolment.
* hyperparathyroidism or undergoing parathyroidectomy.
* diseases affecting vitamin D absorption, such as long-term diarrhea, chronic pancreatitis, biliary obstruction, colitis, partial resection of the small intestine.
* severe liver and kidney diseases.
* severe peripheral or central neuropathy.
* heart failure.
* pneumonia.
* parenteral nutrition patients.
20 Years
65 Years
FEMALE
No
Sponsors
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Fayoum University
OTHER
Responsible Party
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Mohamed Ahmed Hamed
Associate professor of anaesthesiology
Principal Investigators
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Mohamed A Hamed, A.professor
Role: PRINCIPAL_INVESTIGATOR
Faculty of medicine , Fayoum university
Locations
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Fayoum university hospital
El Fayoum Qesm, Faiyum Governorate, Egypt
Countries
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References
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Zeng X, Chen X, Li C, Shi H. Preoperative Vitamin D Level is Associated with Acute Pain After Video-Assisted Thoracoscopic Surgery: A Retrospective Cohort Study. J Pain Res. 2022 Oct 12;15:3189-3196. doi: 10.2147/JPR.S382407. eCollection 2022.
Roth DE, Abrams SA, Aloia J, Bergeron G, Bourassa MW, Brown KH, Calvo MS, Cashman KD, Combs G, De-Regil LM, Jefferds ME, Jones KS, Kapner H, Martineau AR, Neufeld LM, Schleicher RL, Thacher TD, Whiting SJ. Global prevalence and disease burden of vitamin D deficiency: a roadmap for action in low- and middle-income countries. Ann N Y Acad Sci. 2018 Oct;1430(1):44-79. doi: 10.1111/nyas.13968. Epub 2018 Sep 18.
Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
Imtiaz S, Siddiqui N, Raza SA, Loya A, Muhammad A. Vitamin D deficiency in newly diagnosed breast cancer patients. Indian J Endocrinol Metab. 2012 May;16(3):409-13. doi: 10.4103/2230-8210.95684.
Bose S, Khanna A, You J, Arora L, Qavi S, Turan A. Low serum vitamin D levels are not associated with increased postoperative pain and opioid requirements: a historical cohort study. Can J Anaesth. 2015 Jul;62(7):770-6. doi: 10.1007/s12630-015-0357-4. Epub 2015 Mar 10.
Ulitsky A, Ananthakrishnan AN, Naik A, Skaros S, Zadvornova Y, Binion DG, Issa M. Vitamin D deficiency in patients with inflammatory bowel disease: association with disease activity and quality of life. JPEN J Parenter Enteral Nutr. 2011 May;35(3):308-16. doi: 10.1177/0148607110381267.
Martinez-Alonso M, Dusso A, Ariza G, Nabal M. Vitamin D deficiency and its association with fatigue and quality of life in advanced cancer patients under palliative care: A cross-sectional study. Palliat Med. 2016 Jan;30(1):89-96. doi: 10.1177/0269216315601954. Epub 2015 Aug 27.
Sharma GN, Dave R, Sanadya J, Sharma P, Sharma KK. Various types and management of breast cancer: an overview. J Adv Pharm Technol Res. 2010 Apr;1(2):109-26.
Welsh J. Vitamin D and breast cancer: Past and present. J Steroid Biochem Mol Biol. 2018 Mar;177:15-20. doi: 10.1016/j.jsbmb.2017.07.025. Epub 2017 Jul 23.
Feldman D, Krishnan AV, Swami S, Giovannucci E, Feldman BJ. The role of vitamin D in reducing cancer risk and progression. Nat Rev Cancer. 2014 May;14(5):342-57. doi: 10.1038/nrc3691. Epub 2014 Apr 4.
Deeb KK, Trump DL, Johnson CS. Vitamin D signalling pathways in cancer: potential for anticancer therapeutics. Nat Rev Cancer. 2007 Sep;7(9):684-700. doi: 10.1038/nrc2196.
Altieri B, Grant WB, Della Casa S, Orio F, Pontecorvi A, Colao A, Sarno G, Muscogiuri G. Vitamin D and pancreas: The role of sunshine vitamin in the pathogenesis of diabetes mellitus and pancreatic cancer. Crit Rev Food Sci Nutr. 2017 Nov 2;57(16):3472-3488. doi: 10.1080/10408398.2015.1136922.
Meeker S, Seamons A, Maggio-Price L, Paik J. Protective links between vitamin D, inflammatory bowel disease and colon cancer. World J Gastroenterol. 2016 Jan 21;22(3):933-48. doi: 10.3748/wjg.v22.i3.933.
Jacobs ET, Kohler LN, Kunihiro AG, Jurutka PW. Vitamin D and Colorectal, Breast, and Prostate Cancers: A Review of the Epidemiological Evidence. J Cancer. 2016 Jan 5;7(3):232-40. doi: 10.7150/jca.13403. eCollection 2016.
Xia J, Li D, Yu G, Xu B, Gao X, Wang H, Ma Y, Li X, Xiong Y. Effects of Hypovitaminosis D on Preoperative Pain Threshold and Perioperative Opioid Use in Colorectal Cancer Surgery: A Cohort Study. Pain Physician. 2022 Oct;25(7):E1009-E1019.
Other Identifiers
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D328
Identifier Type: -
Identifier Source: org_study_id
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