Analgesic and Anti-inflamatory Effect of Vit. B

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-05-01

Brief Summary

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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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Detailed Description

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Conditions

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Postoperative Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group B

Group Type EXPERIMENTAL

Vitamin B Complex

Intervention Type 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 .

Group C

Group Type EXPERIMENTAL

vitamin C

Intervention Type 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 .

Group N

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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 .

Intervention Type 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 .

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes