Ignite Creation Date:
2024-05-05 @ 11:25 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01322061
Status:
COMPLETED
Last Update Posted:
2012-01-09
First Post:
2011-03-09
Brief Title:
Vitamin C Efficacy in Reducing Post Operative Pain
Sponsor:
American University of Beirut Medical Center
Organization:
American University of Beirut Medical Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 nauseavomiting 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 nauseavomiting 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
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 nauseavomiting 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 nauseavomiting 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AUBMC | OTHER | AUBMC | None |