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NCT Number: NCT06857734

Analgesic and Anti-inflamatory Effect of Vit. B

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.

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Key information

Conditions

Postoperative Pain, Acute Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin B Complex

Drug

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 .

Vitamin C

Drug

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 .

Placebo

Drug

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 outcomes

  1. The total dose of analgesics required postoperatively

    Time frame: within the first 24 hours and the time to first request

Study contacts

Contact information is provided by the study sponsor or research team.

Islam M Hosainy, Master

CONTACT

[email protected]

+201287466883

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Acronym: vit B/vit C

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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