Gallbladder Inflammation Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | July 2011 |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Lebanon | AUBMC | Beirut |
| Lead Sponsor | Collaborator |
|---|---|
| American University of Beirut Medical Center |
Lebanon,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | sedation score on the Ramsey scale | Sedation score will be measured in PACU and up 24 hours upon discharge from PACU | No | |
| Secondary | 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 | No |
| Secondary | Incidence of itching | Itching incidence will be measured in PACU and up 24 hours upon discharge from PACU | No | |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05712733 -
Cholecystitis From a Microbiological and Histopathological Perspective
|