Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy

Taeho Hong

Status: Unknown

Conditions: Cholelithiasis; Chronic Cholecystitis

Treatments: Drug: Placebo; Drug: Vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT02553551

Seoul-06

Details and patient eligibility

About

The aim of this study is to evaluate the effect of Vitamine C supplements to be helpful to reduce the postoperative pain after laparoscopic cholecystectomy through the double-blinded randomized controlled trial.

Full description

The aim of this study is to evaluate the effect of Vitamine C supplements to be helpful to reduce the postoperative pain after laparoscopic cholecystectomy through the double-blinded randomized controlled trial.

The primary purpose of this study is to confirm the reduce of postoperative pain through the oral supplement of Vitamine C before and after the surgery. For this purpose, we compared the dosage or counts of opioids usage with the oral supplement of Vitamine C or not.

The secondary purpose is to assess the pain score, postoperative morbidities, postoperative length of stay or postoperative time between two groups.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic cholecystitis
• gallbladder polyp

Exclusion criteria

• grade I Tokyo guideline for acute cholecystitis
• grade II Tokyo guideline for acute cholecystitis without the evidence of gallbladder perforation
• gallbladder cancer
• the patient who underwent reduced port surgery
• the patient who underwent common bile duct exploration during the operation
• the patient who underwent concurrent operation
• the patient who had past history of upper abdominal surgery
• the patient who had a immunodeficiency state
• the case which had a suspicion of delayed bile leakage
• the case which had a incomplete cystic duct ligation
• the patient who underwent open conversion surgery during the operation
• the patient who had a high risk of bleeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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320 participants in 2 patient groups, including a placebo group

Vitamin C

Experimental group

Description:

During the period of hospitalization, Intake of vitamin C 3000 mg per day via oral route until the day of discharge. After discharge, no additional vitamin C pill was given.

Treatment:

Drug: Vitamin C

Placebo

Placebo Comparator group

Description:

During the period of hospitalization, Intake of gelatinous capsule three times per day via oral route until the day of discharge. After discharge, no additional capsule was given.

Treatment:

Drug: Placebo