Vitamin C Efficacy in Reducing Post Operative Pain

The Role of a Single Oral Dose (2g) of Vitamin C in Reducing Intensity of Pain and Opioids Consumption in Patients Undergoing Laparoscopic Cholecystectomy. A Randomized, Double-blinded, Placebo-controlled Study

Opioids are the corner stone in the treatment of post operative pain. Because of the several side effects of opiods, non-steroidal anti-inflammatory drugs are usually added postoperatively to decrease the total requirements of opioids. However, non steroidal anti-inflammatory drugs have side effects of their own. Vitamin C, with virtually no side effects when used on short-term basis, has been shown to have promising analgesic effects in chronic pain and acute pain relief following orthopedic surgeries.

The investigators propose to assess the role of a prophylactic single dose (2g) of vitamin C in reducing the intensity of pain and the consumption of opioids in patients undergoing laparoscopic cholecystectomy at AUB-MC.

All eligible patients undergoing laparoscopic cholecystectomy at AUB-MC will be included in the study. Patients will be randomized into two groups to receive either single dose oral vitamin C (2g) (Study Group) or identically looking placebo capsules (Control Group). Both the patients and the investigation team will be blinded to the type of intervention. Intraoperative anesthesia management will be similar for both groups. Postoperative pain control will be achieved with patient controlled analgesia via a patient controlled morphine pump in both groups. At several time intervals and up to 24 hours postoperatively, the pain scores, morphine consumptions, nausea/vomiting scores, sedation scales, itching scales, and patient satisfaction scales will be obtained for all patients. Also, the peak vitamin C concentration will be determined for each patient.

Patients demographics will be obtained and compared between both groups. The differences in pain scores, morphine consumptions, nausea/vomiting scores, and sedation, itching, and patient satisfaction scales will be compared between the two groups with the Student-t test, the analysis of variance, the Fisher exact test, and the Kruskal-Wallis test. The peak vitamin C plasma concentration will be correlated with the pain scores in each group using regression analysis.

This study will provide relevant information on whether a single dose (2g) of vitamin C can reduce morphine requirements and non steroidal anti-inflammatory drugs need and thus eliminating their side effects in patients undergoing laparoscopic cholecystectomy.

Study Overview

• Status: Completed
• Conditions: Gallbladder Inflammation
• Intervention / Treatment: Drug: Ascorbic Acid

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • AUBMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients of both gender
• Between 18-75 years old
• ASA class I, II, or III
• Scheduled to undergo laparoscopic cholecystectomy

Exclusion Criteria:

• Intake of anti-inflammatory drug in the past 24 hr
• Allergy to morphine
• History of chemical dependence
• Chronic pain state
• Inability to use PCA pumps
• History of obstructive sleep apnea
• History of severe asthma
• History of COPD
• History of gastroesophageal reflux disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vitamin C	Drug: Ascorbic Acid; Effervescent,1000mg/tablet, 2000 mg dissolved in 50ml water, the drug will be given once, one hour prior to surgery; Other Names: Redoxon, Vitamin C 1000mg, Bayer LSR912 MFD
Placebo Comparator: mirinda	Drug: Ascorbic Acid; Effervescent,1000mg/tablet, 2000 mg dissolved in 50ml water, the drug will be given once, one hour prior to surgery; Other Names: Redoxon, Vitamin C 1000mg, Bayer LSR912 MFD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total morphine consumption	During their stay in the PACU (Post Anesthesia Care Unit), patients in both groups will be started on a morphine IV PCA pump that is programmed to deliver on patient's demand 1mg every 6 minutes with a total limit of 30mg every 4 hours for post operative relief.Patients will be followed up after discharge from PACU and morphine consumption will be recorded	total morphine consumption in 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sedation score on the Ramsey scale		Sedation score will be measured in PACU and up 24 hours upon discharge from PACU
incidence of nausea and vomiting	Nausea/Vomiting will be monitored using Verbal Rating Score (VRS). The number of vomiting episodes will be recorded. Episodes of vomiting occurring less than 5 min-apart will be considered as one episode.	Nausea and vomiting incidence will be monitored in PACU and up 24 hours upon discharge from PACU
Incidence of itching		Itching incidence will be measured in PACU and up 24 hours upon discharge from PACU
patient satisfaction scale	Patient satisfaction scale measures the overall patient's satisfaction regarding the post-operative experience in terms of pain managment. The scale is divided into four main categories: Excellent, Good, Fair,Poor.	patient satisfaction scale will be measured in PACU and up 24 hours upon discharge from PACU
Pain score on the Visual Analog Scale	During their stay in the PACU, the incisional, visceral and shoulder pain intensity for each patient will be measured using Visual Analog Scale (VAS)and/or Verbal Rating Score.	Pain will be measured in PACU and up to 24 hours upon discharge from PACU

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Ghassan Kanazi, MD, AUBMC

Publications and helpful links

General Publications

• Kanazi GE, El-Khatib MF, Yazbeck-Karam VG, Hanna JE, Masri B, Aouad MT. Effect of vitamin C on morphine use after laparoscopic cholecystectomy: a randomized controlled trial. Can J Anaesth. 2012 Jun;59(6):538-43. doi: 10.1007/s12630-012-9692-x. Epub 2012 Mar 9.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: March 9, 2011
• First Submitted That Met QC Criteria: March 23, 2011
• First Posted (Estimate): March 24, 2011

Study Record Updates

• Last Update Posted (Estimate): January 9, 2012
• Last Update Submitted That Met QC Criteria: January 6, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: acute cholecystitis; Gallbladder removal; Laparoscopic cholecestectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gallbladder Diseases; Biliary Tract Diseases; Inflammation; Cholecystitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: ANES.GK.06; AUBMC (Other Identifier: AUBMC)