Vitamin CNCT05770596
Vitamin C on Acute and Chronic Post Mastectomy Pain
A study testing vitamin C group in people with Vitamin C and Post-mastectomy Pain Syndrome, run by Tanta University at 1 site in Egypt.
Trial summary
This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of perioperative vitamin C on acute and chronic post mastectomy pain after breast cancer surgery Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vitamin C, Post-mastectomy Pain Syndrome
- What is being tested?
- vitamin C group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 3 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥ 18years, with primary unilateral breast cancer and scheduled for lumpectomy, partial or total mastectomy with or without axillary lymph node dissection or modified radical mastectomy.
Who cannot join
- (1) Patients with renal stones or renal insufficiency, patients suffering from nausea and vomiting, gastroesophageal reflux or patients with chronic pain state.
- Intake of analgesic within 24 hours before surgery. (3) Patients unable to comply with the study protocol for any reason. (4) Contraindications to paravertebral block (PVB) such as allergy to local anesthetics, infection, or coagulopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Perioperative Vitamin C on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery
This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of perioperative vitamin C on acute and chronic post mastectomy pain after breast cancer surgery
Read the detailed description
There is cumulative evidence that postoperative pain is closely associated with subsequent persistent pain lasting months. The International Association for the Study of Pain has defined chronic postsurgical pain (CPSP) as a pain that develops after surgical intervention and persists at least 2 months.
- Conditions
- Vitamin C, Post-mastectomy Pain Syndrome
- Being tested
- vitamin C group, placebo group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin C groupDrug
patients in this group will receive 2 gm vitamin C orally 1 hour before surgery and will receive 0.5 gm vitamin C per day orally for 50 days starting from the 2nd postoperative day.
placebo groupOther
patients in this group will receive placebo tablets with the same manner; orally 1 hour before surgery and for 50 days starting from the 2nd postoperative day.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C group | Experimental | patients in this group will receive 2 gm vitamin C orally 1 hour before surgery and will receive 0.5 gm vitamin C per day orally for 50 days starting from the 2nd postoperative day. Receives: Drug: vitamin C group |
| Placebo group | Placebo comparator | patients in this group will receive placebo tablets with the same manner.1 hour before surgery and for 50 days starting from the 2nd postoperative day. Receives: Other: placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of chronic post mastectomy pain
Chronic pain will be assessed at 3, 6 months after surgery. Chronic pain will be defined as pain at the surgical site greater than or equal to 3 out of 10 on item 5 of the Brief Pain Inventory (item 5: "Please rate your pain by circling the one number that best describes your pain on the average in the past 24h, no pain = 0, worst pain = 10")
Measured: 6 months after surgery
Secondary outcomes (4)
The degree of acute postoperative pain
degree of acute postoperative pain scores in the 1st and 2nd postoperative days using visual analogue scale (VAS) in both groups.
Postoperative pain using VAS scores: will be assessed at 1, 4, 6, 12, 18, 24, 30, 36, 42 and 48 hr. after surgery.
0: No pain, 10: the worst pain
Measured: 48 hours postoperative
The amount of total opioid dose in 48 hours after surgery
Postoperative pain in the 1st and 2nd days will be assessed using VAS scores. If VAS score more than or equal to 4, morphine 0.05 mg/kg will be given.
Measured: 48 hours postoperative
The incidence of adverse effects
postoperative adverse effects like postoperative nausea and vomiting (PONV).
Measured: 48 hours postoperative
The incidence of chronic pain at 9, 12 months after surgery
Chronic pain will be assessed at 9, 12 months after surgery
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Apr 2023
- Primary completion3 Dec 2024
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin CStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Rehab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770596
- Sponsor's protocol ID
- 36264PR116/2/23
- Status last verified
- Dec 2025
- First submitted
- 5 Mar 2023
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perioperative Vitamin C on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT05770596
- Acronym / sponsor ID
- 36264PR116/2/23
- Conditions
- Vitamin C, Post-mastectomy Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of perioperative vitamin C on acute and chronic post mastectomy pain after breast cancer surgery
Detailed description
There is cumulative evidence that postoperative pain is closely associated with subsequent persistent pain lasting months. The International Association for the Study of Pain has defined chronic postsurgical pain (CPSP) as a pain that develops after surgical intervention and persists at least 2 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C group | Experimental | Drug: vitamin C grouppatients in this group will receive 2 gm vitamin C orally 1 hour before surgery and will receive 0.5 gm vitamin C per day orally for 50 days starting from the 2nd postoperative day. |
| Placebo group | Placebo comparator | Other: placebo grouppatients in this group will receive placebo tablets with the same manner.1 hour before surgery and for 50 days starting from the 2nd postoperative day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients aged ≥ 18years, with primary unilateral breast cancer and scheduled for lumpectomy, partial or total mastectomy with or without axillary lymph node dissection or modified radical mastectomy.
Key exclusion criteria (2 listed)
- (1) Patients with renal stones or renal insufficiency, patients suffering from nausea and vomiting, gastroesophageal reflux or patients with chronic pain state.
- Intake of analgesic within 24 hours before surgery. (3) Patients unable to comply with the study protocol for any reason. (4) Contraindications to paravertebral block (PVB) such as allergy to local anesthetics, infection, or coagulopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin C grouppatients in this group will receive 2 gm vitamin C orally 1 hour before surgery and will receive 0.5 gm vitamin C per day orally for 50 days starting from the 2nd postoperative day. | Drug | Vitamin C group |
| placebo grouppatients in this group will receive placebo tablets with the same manner; orally 1 hour before surgery and for 50 days starting from the 2nd postoperative day. | Other | Placebo group |
Primary outcome
The incidence of chronic post mastectomy pain
Time frame: 6 months after surgery
Chronic pain will be assessed at 3, 6 months after surgery. Chronic pain will be defined as pain at the surgical site greater than or equal to 3 out of 10 on item 5 of the Brief Pain Inventory (item 5: "Please rate your pain by circling the one number that best describes your pain on the average in the past 24h, no pain = 0, worst pain = 10")
4 secondary outcomes
The degree of acute postoperative pain
Time frame: 48 hours postoperative
The amount of total opioid dose in 48 hours after surgery
Time frame: 48 hours postoperative
The incidence of adverse effects
Time frame: 48 hours postoperative
The incidence of chronic pain at 9, 12 months after surgery
Time frame: 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin C group in people with Vitamin C and Post-mastectomy Pain Syndrome, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of chronic post mastectomy pain (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.