Vitamin C Efficacy in Reducing Post Operative Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ghassan Kanazi, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT01322061
First received: March 9, 2011
Last updated: January 6, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Gallbladder Inflammation
Drug: Ascorbic Acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by American University of Beirut Medical Center:

Primary Outcome Measures:
  • total morphine consumption [ Time Frame: total morphine consumption in 24 hours ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • sedation score on the Ramsey scale [ Time Frame: Sedation score will be measured in PACU and up 24 hours upon discharge from PACU ] [ Designated as safety issue: No ]
  • incidence of nausea and vomiting [ Time Frame: Nausea and vomiting incidence will be monitored in PACU and up 24 hours upon discharge from PACU ] [ Designated as safety issue: No ]
    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.

  • Incidence of itching [ Time Frame: Itching incidence will be measured in PACU and up 24 hours upon discharge from PACU ] [ Designated as safety issue: No ]
  • patient satisfaction scale [ Time Frame: patient satisfaction scale will be measured in PACU and up 24 hours upon discharge from PACU ] [ Designated as safety issue: No ]
    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.

  • Pain score on the Visual Analog Scale [ Time Frame: Pain will be measured in PACU and up to 24 hours upon discharge from PACU ] [ Designated as safety issue: No ]
    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.


Enrollment: 80
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Redoxon, Vitamin C 1000mg, Bayer LSR912 MFD

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322061

Locations
Lebanon
AUBMC
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
Principal Investigator: Ghassan Kanazi, MD AUBMC
  More Information

No publications provided by American University of Beirut Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ghassan Kanazi, Associate Professor, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT01322061     History of Changes
Other Study ID Numbers: ANES.GK.06, AUBMC
Study First Received: March 9, 2011
Last Updated: January 6, 2012
Health Authority: Lebanon: Institutional Review Board

Keywords provided by American University of Beirut Medical Center:
Gallbladder removal
acute cholecystitis
Laparoscopic cholecestectomy

Additional relevant MeSH terms:
Cholecystitis
Inflammation
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Pathologic Processes
Ascorbic Acid
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 15, 2014