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Not yet recruiting NCT06857734

Analgesic and Anti-inflamatory Effect of Vit. B

No phase Interventional Postoperative Pain, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin B Complex, vitamin C, Placebo.
Who it may be relevant to
Registry conditions: Postoperative Pain, Acute. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Analgesic and Anti-inflamatory Effect of Vitamin B Versus Vitamin C Infusion in Patients Undergoing Laparoscopic Cholecystectomy ; a Randomized Controlled Trial

Overview

Vitamin C, also known as ascorbic acid, is a potent reducing agent and antioxidant that plays a crucial role in various metabolic processes.Vitamin B complex, a group of eight essential B vitamins, plays a crucial role in cellular metabolism, energy production, and maintaining nervous system health. There are few available studies on the effects of vitamin B injection on plasma inflammatory markers and its adjuvant analgesic effect along with the routine multimodal analgesia. Considering limited research and existing controversies in this field, the aim of present study is to evaluate the effects of preoperative and intraoperative vitamin B12 administration compared to vitamin C when used as a component of the multimodal analgesic technique in patients undergoing laparoscopic cholecystectomy.

Interventions

  • Drug Vitamin B Complex
    group of vit. B will recieve as an oral capsules for 4 days preoperative , and infusion of vitamin B complex 1ml diluted in 100 ml normal saline administered intravenously after anathesia induction .
  • Drug vitamin C
    group of vitamin C will recieve 1000 mg as an oral capsule for 4 days and infusion at dose of 50 mg/kg diluted in 100 ml normal saline administered iv after induction of anathesia .
  • Drug Placebo
    patients will recieve placebo tablets with identical regimen preoperative and a placebo infusion of 100 ml normal saline after induction of anathesia ,prepared with identical appearance and taste by the pharmacist according to the randomization group.

Primary outcome measures

  • The total dose of analgesics required postoperatively [Time frame: within the first 24 hours and the time to first request]

Eligibility criteria

Inclusion criteria

  • Adult patients (age 18-60 years)
  • American Society of Anesthesiologists (ASA) classification I-II
  • Patients undergoing laparoscopic cholecystectomy under general anaesthesia

Exclusion criteria

  • Hypersensitivity to vitamin B complex or vitamin C
  • History of chronic pain or use of opioids within the last month
  • Patient with inflammatory conditions
  • Severe renal or hepatic impairment
  • Patient with intellectual disabilities.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Benha university — Banhā

Identifiers

NCT: NCT06857734 · Ms 33-12-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗