Post-mastectomy Pain Syndrome, Vitamin C
Conditions
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.
Interventions
DRUGvitamin 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.
OTHERplacebo 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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed