Vitamin C on Acute and Chronic Post Mastectomy Pain

Sponsor

Tanta University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05770596

Collaborator

(none)

204

Enrollment

Location

Arms

Anticipated Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Vitamin C Post-mastectomy Pain Syndrome	Drug: vitamin C group Other: placebo group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

204 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Impact of Perioperative Vitamin C on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 3 morphine 0.05mg/kg will be given.
The incidence of adverse effects [48 hours postoperative]
postoperative adverse effects like postoperative nausea and vomiting (PONV).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University	Tanta	Gharbiya	Egypt	31527

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Osama Rehab, Lecturer of anesthesiology, S.I.C.U and pain medicine Tanta university, Tanta University

ClinicalTrials.gov Identifier:

NCT05770596

Other Study ID Numbers:

36264PR116/2/23

First Posted:

Mar 15, 2023

Last Update Posted:

Mar 15, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 15, 2023