Vitamin C Efficacy in Reducing Post Operative Pain

American University of Beirut Medical Center

Status and phase: Completed; Phase 4

Conditions: Gallbladder Inflammation

Treatments: Drug: Ascorbic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01322061

AUBMC (Other Identifier)

ANES.GK.06

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Vitamin C

Active Comparator group

Treatment:

Drug: Ascorbic Acid

mirinda

Placebo Comparator group

Treatment:

Drug: Ascorbic Acid