Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy

Cholelithiasis Clinical Trial

Official title:

Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy; a A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02553551
• Other study ID #: Seoul-06
• Status: Recruiting
• Phase: N/A
• First received: September 13, 2015
• Last updated: October 17, 2016
• Start date: July 2015
• Est. completion date: September 2017

Study information

• Verified date: October 2016
• Source: Seoul St. Mary's Hospital
• Contact: Taeho Hong
• Phone: 821052065266
• Email: gshth[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystolithiasis
• Cholelithiasis
• Chronic Cholecystitis
• Gallstones
• Pain, Postoperative

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of HBP Surgery, Seoul St. Mary's hospital	Seoul	Seocho-gu, Banopo-dong

Sponsors (1)

Lead Sponsor	Collaborator
Taeho Hong

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The postoperative pain	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.	The change of pain score between 6hours after operation and 24hours after operation	No
Secondary	Postoperative morbidity	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.	30 days	No