Vitamin C on Acute and Chronic Post Mastectomy Pain

Tanta University204 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

204

Conditions

Vitamin C Post-mastectomy Pain Syndrome

Interventions

vitamin C groupDRUG

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 groupOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta University

Tanta, Gharbia Governorate, Egypt

Outcomes

Primary Outcomes

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")

Time frame: 6 months after surgery

Secondary Outcomes

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

Time frame: 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 or equal to 4, morphine 0.05 mg/kg will be given.

Time frame: 48 hours postoperative

The incidence of adverse effects

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

Time frame: 48 hours postoperative

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

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

Time frame: 12 months after surgery

Data from ClinicalTrials.gov

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