Vitamin C on Acute and Chronic Post Mastectomy Pain

Post-mastectomy Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05770596
• Other study ID #: 36264PR116/2/23
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: Tanta University
• Contact: Osama M Rehab, MD
• Phone: 00201095210806
• Email: osamarehab16988[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: June 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Post-mastectomy Pain Syndrome
• Vitamin C

Intervention

Drug:
• 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.

Other:
• placebo group
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.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	Gharbiya

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	48 hours postoperative
Secondary	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 3 morphine 0.05mg/kg will be given.	48 hours postoperative
Secondary	The incidence of adverse effects	postoperative adverse effects like postoperative nausea and vomiting (PONV).	48 hours postoperative