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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin C group | Experimental | 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. |
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| Placebo group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin C group | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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.
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | Gharbia Governorate | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author.
The data will be available upon a reasonable request from the corresponding author after the end of study for 1 year.
The data will be available upon a reasonable request from the corresponding author.
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| placebo group | Other | 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. |
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| 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. |
| 48 hours postoperative |
| The incidence of adverse effects | postoperative adverse effects like postoperative nausea and vomiting (PONV). | 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 | 12 months after surgery |