Vitamin C Efficacy in Reducing Post Operative Pain

NCT01322061 | Completed Phase 4 DMC

• 2 other identifiers: ANES.GK.06AUBMC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Gallbladder removal; acute cholecystitis; Laparoscopic cholecestectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• sedation score on the Ramsey scale

  Sedation score will be measured in PACU and up 24 hours upon discharge from PACU

• incidence of nausea and vomiting

  Nausea and vomiting incidence will be monitored in PACU and up 24 hours upon discharge from PACU

• Incidence of itching

  Itching incidence will be measured in PACU and up 24 hours upon discharge from PACU

• patient satisfaction scale

  patient satisfaction scale will be measured in PACU and up 24 hours upon discharge from PACU

• Pain score on the Visual Analog Scale

  Pain will be measured in PACU and up to 24 hours upon discharge from PACU

Study Arms (2)

Vitamin C

ACTIVE COMPARATOR

Drug: Ascorbic Acid

mirinda

PLACEBO COMPARATOR

Drug: Ascorbic Acid

Interventions

Ascorbic Acid DRUG

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

Also known as: Redoxon, Vitamin C 1000mg, Bayer LSR912 MFD

Vitamin C; mirinda

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both gender
• Between 18-75 years old
• ASA class I, II, or III
• Scheduled to undergo laparoscopic cholecystectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

AUBMC

Beirut, Beyrouth, Lebanon

Location

Related Publications (1)

• 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.

  PMID: 22402954 DERIVED

MeSH Terms

Conditions

Cholecystitis; Cholecystitis, Acute

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Ghassan Kanazi, MD

  AUBMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 24, 2011
• Study Start: November 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 9, 2012

Record last verified: 2012-01

Locations

LE (1)