Vitamin C Efficacy in Reducing Post Operative Pain
Primary Purpose
Gallbladder Inflammation
Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
Ascorbic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Gallbladder Inflammation focused on measuring Gallbladder removal, acute cholecystitis, Laparoscopic cholecestectomy
Eligibility 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
Sites / Locations
- AUBMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin C
mirinda
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
sedation score on the Ramsey scale
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.
Incidence of itching
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.
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.
Full Information
NCT ID
NCT01322061
First Posted
March 9, 2011
Last Updated
January 6, 2012
Sponsor
American University of Beirut Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01322061
Brief Title
Vitamin C Efficacy in Reducing Post Operative Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Inflammation
Keywords
Gallbladder removal, acute cholecystitis, Laparoscopic cholecestectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin C
Arm Type
Active Comparator
Arm Title
mirinda
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ascorbic Acid
Other Intervention Name(s)
Redoxon, Vitamin C 1000mg, Bayer LSR912 MFD
Intervention Description
Effervescent,1000mg/tablet, 2000 mg dissolved in 50ml water, the drug will be given once, one hour prior to surgery
Primary Outcome Measure Information:
Title
total morphine consumption
Description
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
Time Frame
total morphine consumption in 24 hours
Secondary Outcome Measure Information:
Title
sedation score on the Ramsey scale
Time Frame
Sedation score will be measured in PACU and up 24 hours upon discharge from PACU
Title
incidence of nausea and vomiting
Description
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.
Time Frame
Nausea and vomiting incidence will be monitored in PACU and up 24 hours upon discharge from PACU
Title
Incidence of itching
Time Frame
Itching incidence will be measured in PACU and up 24 hours upon discharge from PACU
Title
patient satisfaction scale
Description
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.
Time Frame
patient satisfaction scale will be measured in PACU and up 24 hours upon discharge from PACU
Title
Pain score on the Visual Analog Scale
Description
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.
Time Frame
Pain will be measured in PACU and up to 24 hours upon discharge from PACU
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghassan Kanazi, MD
Organizational Affiliation
AUBMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
AUBMC
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
Citations:
PubMed Identifier
22402954
Citation
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.
Results Reference
derived
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Vitamin C Efficacy in Reducing Post Operative Pain
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