Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy

Not Applicable

• Conditions: Chronic Cholecystitis; Cholelithiasis
• Interventions: Drug: Placebo; Drug: Vitamin C

• Registration Number: NCT02553551
• Lead Sponsor: Taeho Hong

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-09-13
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Vitamin C	Vitamin C	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.

Primary Outcome Measures

Name	Time	Method
The postoperative pain	The change of pain score between 6hours after operation and 24hours after operation	Postoperative pain was estimated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain imaginable) at 6, 24, and 48 hours after the operation.

Secondary Outcome Measures

Name	Time	Method
Postoperative morbidity	30 days	the incidence of complications after surgery during one month after surgery such as postoperative fever, atelectasis, infectious complications, bile leak, postoperative bleeding, readmission or mortality.

Trial Locations

Locations (1)

Department of HBP Surgery, Seoul St. Mary's hospital; 🇰🇷 Seoul, Seocho-gu, Banopo-dong, Korea, Republic of