Vitamin C Efficacy in Reducing Post Operative Pain

NCT ID: NCT01322061

Last Updated: 2012-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-07-31

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.

Conditions

Gallbladder Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vitamin C

Group Type: ACTIVE_COMPARATOR

Ascorbic Acid

Intervention Type: DRUG

Effervescent,1000mg/tablet, 2000 mg dissolved in 50ml water, the drug will be given once, one hour prior to surgery

mirinda

Group Type: PLACEBO_COMPARATOR

Ascorbic Acid

Intervention Type: DRUG

Effervescent,1000mg/tablet, 2000 mg dissolved in 50ml water, the drug will be given once, one hour prior to surgery

Interventions

Ascorbic Acid

Effervescent,1000mg/tablet, 2000 mg dissolved in 50ml water, the drug will be given once, one hour prior to surgery

Intervention Type: DRUG

Other Intervention Names

Redoxon, Vitamin C 1000mg, Bayer LSR912 MFD

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ghassan Kanazi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghassan Kanazi, MD

Role: PRINCIPAL_INVESTIGATOR

AUBMC

Locations

AUBMC

Beirut, Beyrouth, Lebanon

Countries

Lebanon

References

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.

Reference Type: DERIVED

PMID: 22402954 (View on PubMed)

Other Identifiers

AUBMC

Identifier Type: OTHER

Identifier Source: secondary_id

ANES.GK.06

Identifier Type: -

Identifier Source: org_study_id