Analgesic and Anti-inflamatory Effect of Vit. B

ConditionPostoperative Pain, Acute

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorBenha University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult patients (age 18-60 years)

American Society of Anesthesiologists (ASA) classification I-II

Patients undergoing laparoscopic cholecystectomy under general anaesthesia

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Group BExperimental treatment 1 intervention

Group B: Group CExperimental treatment 1 intervention

Group C: Group NPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

The total dose of analgesics required postoperatively

Time frame

within the first 24 hours and the time to first request

Sponsors and contacts

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Benha University

Lead sponsor

Source ClinicalTrials.gov

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