Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy

NCT ID: NCT02553551

Last Updated: 2016-10-18

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Chronic Cholecystitis Cholelithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Vitamin placebo capsule

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taeho Hong

OTHER

Sponsor Role lead

Responsible Party

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Taeho Hong

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Taeho Hong

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Department of HBP Surgery, Seoul St. Mary's hospital

Seoul, Seocho-gu, Banopo-dong, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Taeho Hong

Role: CONTACT

821052065266

Facility Contacts

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Taeho Hong

Role: primary

+82-2-2258-6108

Other Identifiers

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Seoul-06

Identifier Type: -

Identifier Source: org_study_id

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