Vitamin C on Acute and Chronic Post Mastectomy Pain

NCT05770596 | Completed

• 1 other identifier: 36264PR116/2/23
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Vitamin C; Post-mastectomy Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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")

  6 months after surgery

Secondary Outcomes (4)

• The degree of acute postoperative pain

  48 hours postoperative

• The amount of total opioid dose in 48 hours after surgery

  48 hours postoperative

• The incidence of adverse effects

  48 hours postoperative

• The incidence of chronic pain at 9, 12 months after surgery

  12 months after surgery

Study Arms (2)

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.

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.

Other: placebo group

Interventions

vitamin C group DRUG

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.

Vitamin C group

placebo group OTHER

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.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- (1) Patients with renal stones or renal insufficiency, patients suffering from nausea and vomiting, gastroesophageal reflux or patients with chronic pain state.
• (2) 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesiology, S.I.C.U and pain medicine Tanta university

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 15, 2023
• Study Start: April 1, 2023
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available upon a reasonable request from the corresponding author after the end of study for 1 year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)