Influence of Preoperative Vitamin D Level on Postoperative Pain in Breast Cancer Surgery Patients

May 2, 2025 updated by: Mohamed Ahmed Hamed, Fayoum University

Influence of Preoperative Vitamin D Level on Postoperative Pain in Breast Cancer Surgery Patients: A Prospective Observational Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Diagnostic test: Serum 25(OH)D level

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.

Study Type

Observational

Enrollment (Actual)

184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Egypt
- Faiyum Governorate
  - Madīnat Al Fayyūm, Faiyum Governorate, Egypt, 63514
    - Fayoum University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

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 Fayoum university hospital.

Description

Inclusion criteria:

Female patients ASA II -III.
aged 20-65 years, who will be scheduled to undergo elective unilateral breast cancer surgery.
modified radical mastectomy.

Exclusion criteria:

Patient refusal.
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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group D vitamin D-deficient group (<30nmol/L)	Diagnostic test: 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)	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of moderate to severe postoperative pain Time Frame: at 12 hours after surgery	Incidence	at 12 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Society of Anaesthesiologists Time Frame: 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	24 hours before operation
Pain assessment by NRS Time Frame: 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	24 hours before operation during the preoperative visit
Previous associated comorbidities Time Frame: 24 hours before operation	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) Time Frame: 24 hours before operation	Level	24 hours before operation
Duration of surgery Time Frame: from start to the end of operation	Duration	from start to the end of operation
Total fentanyl consumption (in micrograms) Time Frame: intraoperative till end of the operation	Pain	intraoperative till end of the operation
Heart rate Time Frame: baseline, every 30 minutes up to end of the operation	measured in beats per minute	baseline, every 30 minutes up to end of the operation
Non- invasive mean arterial blood pressure Time Frame: baseline, every 30 minutes up to end of the operation	measured in mmHg	baseline, every 30 minutes up to end of the operation
Postoperative pain scores Time Frame: 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	at times: hour zero, hour 6, hour12, hour18, hour24 postoperative.
Total tramadol consumption Time Frame: within 1st 24 hours postoperative	measured in mg	within 1st 24 hours postoperative
Incidence of adverse effects Time Frame: 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)	during 1st 24 hours postoperative
Hospital stay Time Frame: 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)	from the date of the operation to the date of discharge from hospital
Patient satisfaction Time Frame: up to 2 days postoperative	will be assessed on a 4-point scale (1: excellent, 2: good 3: fair, 4: poor).	up to 2 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Investigators

Principal Investigator: Mohamed A Hamed, A.professor, Faculty of medicine , Fayoum university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

April 20, 2025

Study Completion (Actual)

April 20, 2025

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

August 9, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Influence of Preoperative Vitamin D Level on Postoperative Pain in Breast Cancer Surgery Patients