Analgesic and Anti-inflamatory Effect of Vit. B

NCT06857734 | Not Yet Recruiting

• 1 other identifier: Ms 33-12-2024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain, Acute

Outcome Measures

Primary Outcomes (1)

• The total dose of analgesics required postoperatively

  within the first 24 hours and the time to first request

Study Arms (3)

Group B

EXPERIMENTAL

Drug: Vitamin B Complex

Group C

EXPERIMENTAL

Drug: vitamin C

Group N

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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 .

Group B

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 .

Group C

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.

Group N

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university

Banhā, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Vitamin B Complex; Ascorbic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Islam M Hosainy, Master

CONTACT

+201287466883; islammoawad229@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 4, 2025
• Study Start: March 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)