Vitamin C on Acute and Chronic Post Mastectomy Pain

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

Study Overview

• Status: Not yet recruiting
• Conditions: Post-mastectomy Pain Syndrome; Vitamin C
• Intervention / Treatment: Drug: vitamin C group; Other: placebo group

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 Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Osama M Rehab, MD; Phone Number: 00201095210806; Email: [email protected]

Study Locations

• Egypt
  • Gharbiya
    • Tanta, Gharbiya, Egypt, 31527
      • Tanta University
      • Contact: Osama M Rehab, MD; Phone Number: 00201095210806; Email: [email protected]
      • Sub-Investigator: Doha M Bakr, MD
      • Sub-Investigator: Mohammed S Elsharkawy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
The incidence of adverse effects	postoperative adverse effects like postoperative nausea and vomiting (PONV).	48 hours postoperative

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: March 5, 2023
• First Submitted That Met QC Criteria: March 5, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: 36264PR116/2/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Time Frame: The data will be available upon a reasonable request from the corresponding author after the end of study for 1 year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No