Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy

Study Overview
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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.

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

Conditions
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Chronic Cholecystitis, Cholelithiasis

Intervention / Treatment
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* Drug: Vitamin C
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin C<br>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. | Drug: Vitamin C<br>* 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.<br>* Other names: Vitamin;|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* 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.<br>* Other names: placebo capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |