Vitamin C Efficacy in Reducing Post Operative Pain
Condition: Gallbladder Inflammation
MeSH terms: Cholecystitis; Inflammation
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): Ascorbic Acid
Intervention type(s): Drug
Intervention description(s): Effervescent,1000mg/tablet, 2000 mg dissolved in 50ml water, the drug will be given once, one hour prior to surgery
Other intervention name(s): Redoxon, Vitamin C 1000mg, Bayer LSR912 MFD
Intervention MeSH terms: Ascorbic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gallbladder removal; acute cholecystitis; Laparoscopic cholecestectomy