Vitamin C on Acute and Chronic Post Mastectomy Pain

Not Applicable

Active, not recruiting

• Conditions: Vitamin C; Post-mastectomy Pain Syndrome
• Interventions: Drug: vitamin C group; Other: placebo group

• Registration Number: NCT05770596
• Lead Sponsor: Tanta University

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

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 Timeline

• Study First Submitted: 2023-03-05
• Study First Submitted QC: 2023-03-05
• Study First Posted: 2023-03-15
• Study Start: 2023-04-01
• Primary Completion: 2024-12-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-09
• Study Completion: 2025-12-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin C group	vitamin C group	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	placebo group	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.

Primary Outcome Measures

Name	Time	Method
The incidence of chronic post mastectomy pain	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 Outcome Measures

Name	Time	Method
The degree of acute postoperative pain	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
The amount of total opioid dose in 48 hours after surgery	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.
The incidence of adverse effects	48 hours postoperative	postoperative adverse effects like postoperative nausea and vomiting (PONV).
The incidence of chronic pain at 9, 12 months after surgery	12 months after surgery	Chronic pain will be assessed at 9, 12 months after surgery

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Gharbiya, Egypt