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NCT Number: NCT05770596

Vitamin C on Acute and Chronic Post Mastectomy Pain

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

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Key information

Conditions

Vitamin C Post-mastectomy Pain Syndrome

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • (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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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")

Secondary outcomes

  1. The degree of acute postoperative pain

    Time frame: 48 hours postoperative

    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

  2. The amount of total opioid dose in 48 hours after surgery

    Time frame: 48 hours postoperative

    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.

  3. The incidence of adverse effects

    Time frame: 48 hours postoperative

    postoperative adverse effects like postoperative nausea and vomiting (PONV).

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

    Time frame: 12 months after surgery

    Chronic pain will be assessed at 9, 12 months after surgery

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Impact of Perioperative Vitamin C on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 15, 2023
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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