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Trial Title:
Vitamin C on Acute and Chronic Post Mastectomy Pain
NCT ID:
NCT05770596
Condition:
Vitamin C
Post-mastectomy Pain Syndrome
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
vitamin C group
Description:
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.
Arm group label:
Vitamin C group
Intervention type:
Other
Intervention name:
placebo group
Description:
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.
Arm group label:
Placebo group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Gender based:
Yes
Gender description:
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.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tanta University
Address:
City:
Tanta
Zip:
31527
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Osama M Rehab, MD
Phone:
00201095210806
Email:
osamarehab16988@yahoo.com
Investigator:
Last name:
Doha M Bakr, MD
Email:
Sub-Investigator
Investigator:
Last name:
Mohammed S Elsharkawy, MD
Email:
Sub-Investigator
Start date:
April 1, 2023
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Tanta University
Agency class:
Other
Source:
Tanta University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05770596
