Clinical trial NCT01322061: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gallbladder Inflammation
Keywords: Gallbladder removal
acute cholecystitis
Laparoscopic cholecestectomy
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: total morphine consumption
timeFrame: total morphine consumption in 24 hours
Secondary outcomes:
measure: sedation score on the Ramsey scale
timeFrame: Sedation score will be measured in PACU and up 24 hours upon discharge from PACU
measure: incidence of nausea and vomiting
timeFrame: Nausea and vomiting incidence will be monitored in PACU and up 24 hours upon discharge from PACU
measure: Incidence of itching
timeFrame: Itching incidence will be measured in PACU and up 24 hours upon discharge from PACU
measure: patient satisfaction scale
timeFrame: patient satisfaction scale will be measured in PACU and up 24 hours upon discharge from PACU
measure: Pain score on the Visual Analog Scale
timeFrame: Pain will be measured in PACU and up to 24 hours upon discharge from PACU
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: AUBMC
Study officials:
affiliation: AUBMC
name: Ghassan Kanazi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.